Device for projecting images on the retina

ABSTRACT

A device to stimulate the retina comprises one or more light sources coupled to one or more optical elements. The one or more optical elements is configured to illuminate the retina with one or more images at a location away from a fovea of a wearer. In some embodiments, each of the one or more images comprises a depth of focus and a spatial resolution. The one or more images can be formed at a distance anterior to the retina, at a distance posterior to the retina or on the retina. In some embodiments, the depth of focus is less than the distance, and the spatial resolution greater than a spatial resolution of the retina at the location.

RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.16/947,537, filed Aug. 5, 2020, is a bypass continuation ofInternational Application No. PCT/US2020/044571, filed Jul. 31, 2020,published as WO 2021/022193 on Feb. 4, 2021, which claims the benefitunder 35 U.S.C. § 119(e) of U.S. Provisional Patent Application No.62/925,948, filed Oct. 25, 2019, of U.S. Provisional Patent ApplicationNo. 62/907,496, filed Sep. 27, 2019, of U.S. Provisional PatentApplication No. 62/885,035, filed Aug. 9, 2019, and of U.S. ProvisionalPatent Application No. 62/881,123, filed Jul. 31, 2019, the entiredisclosures of which are incorporated herein by reference.

BACKGROUND

Myopia, or near-sightedness, is a refractive error in which far objectsare focused anterior to the retina. This can be related to the axiallength of the eye. In general, a 1.0 mm increase in axial length of theeye corresponds to an increase in myopia of 2.5 Diopters (“D”).

Spectacle lenses, contact lenses and refractive surgery can be used totreat refractive errors of the eye such as myopia. Although theseapproaches can be effective in treating myopia, the eye may continue togrow axially, such that the amount of myopia continues to increase. Therelatively high prevalence of myopia has prompted studies to understandthe underlying mechanisms of axial growth and the development ofpossible treatment directed to axial growth.

While myopia is known to have genetic causes, the dramatic increase inthe incidence of myopia cannot be explained by genetic factors alone;rather, they must be interpreted simply as the remarkable ability of thevisual system to adapt to altered environmental conditions, specificallya shift in visual habits from long to short distances and from open toenclosed spaces.

It is known that the retina of many species, including human beingsresponds to defocused images and grows in order to minimize the blurcaused by the defocus. The mechanism of the generation of the growthsignal is still under study, but the one of the observable phenomena ofthe response of retinal tissue to the growth signal is the change inthickness of the choroid. A myopically defocused image can cause thechoroid to grow thicker, thus effectively shortening the axial length ofthe eye, while a hyperopically defocused image can cause the choroid togrow thinner, leading to an increase in axial length. Work in relationto the present disclosure suggests that the change in axial lengthcaused by retinal response to a hyperopic blur or defocus can contributeto myopia development.

While the defocus of images can play a role in choroidal thickness andchanges in the axial length of the eye, the prior methods and apparatusare less than ideally suited to address changes in retinal thickness andaxial length of the eye. For example, pharmaceutical treatments havebeen proposed to treat myopia associated with axial length growth, thesetreatments can have less than ideal results in at least some instances.While atropine and other muscarinic agents can slow myopia progression,possible concerns about post treatment rebound effects and the short andlong-term side effects associated with prolonged treatment may havediscouraged the widespread use of these drugs.

Although animal studies have demonstrated that refractive developmentand axial growth can be regulated by visual feedback associated with theeye's effective refractive status, the methods and apparatus used inthese animal studies are less than ideally suited for the treatment ofmyopia in humans.

Work in relation to the present disclosure suggests that the retinalshell becomes more aspheric as the eye becomes more myopic. Examples ofimage shells on the retina with myopic eyes and traditional correctionare described in Cooper, J, “A Review of Current Concepts of theEtiology and Treatment of Myopia” in Eye & Contact Lens, 2018; 44: pp231. With traditional spherical lenses, the peripheral aspheric retinaof the myopic eye receives light focused behind the retina while lightis focused at the center of the retina, which can trigger a growthsignal because the peripheral light is focused behind the retina,similarly to an eye with insufficient axial length. A conventionalspherical or toric lens (e.g. a contact lens or a spectacle lens)generally cannot generate an image shell that matches the optimum shaperequired for refractive correction that would stop the growth signal tothe retina to become even more myopic. One approach has been to providean aspheric lens that focuses light onto the peripheral regions of theaspheric retina.

Previous refractive correction devices to prevent myopia progression mayproduce less than ideal results in at least some instances. Therefractive correction to provide appropriate focus at the peripheralretina can require a highly aspheric image shell, that can be created bya highly aspheric optic. Unfortunately, such an aspheric optic cangenerate a central image with a substantial aberration, compromising farvision and reducing quality of vision of the wearer in at least someinstances. One approach has been to limit the amount of asphericity toabout 2 D or less in order to provide distance vision withoutsignificant aberrations to central vision, but this limitation on theamount of asphericity can also limit the amount of correction toperipheral portions of the retina, which can lead to a less than idealtreatment in some instances.

A second approach adopted by some prior art devices is to provide abifocal or multifocal optic, comprising a central optical zone dedicatedto correction of refractive error only, while the peripheral zonesgenerally have more plus power to form a myopically defocused image onthe peripheral retina. Ray tracing analyses show that these bifocaloptics can create one or more foci at the fovea, compromising the imagequality at the fovea.

Studies in animal models as well as clinical studies have suggested thatthe retina can distinguish a “plus blur” from a “minus blur”, or imageblur caused by a myopic defocus from a hyperopic defocus, possibly byutilizing longitudinal chromatic aberration as a guide, since the signof the longitudinal chromatic aberration will be opposite, depending onwhether the image blur is hyperopic or myopic. However, prior clinicalapproaches may not have adequately addressed chromatic aberration todecrease myopia progression in at least some instances.

Therefore, new approaches are needed to treat refractive error of theeye and promote changes to axial length of the eye and choroidalthickness that ameliorate at least some of the limitations of the priorapproaches.

SUMMARY

In some embodiments, a device to stimulate to the retina is configuredto project one or more images on the retina that falls outside thefovea. The stimulation can be configured to promote a change in theaxial length and/or choroidal thickness of the eye. The projected imagemay comprise a still image or a dynamic image, for example with arefresh rate in the range from 1 Hz to 500 Hz. The light may comprisemonochromatic or polychromatic light within a range from 400 nm to 800nm. The one or more images can be configured in many ways with an imagestructure corresponding to information or content of the imageassociated with spatial frequencies. In some embodiments, the one ormore images comprises a spatial frequency within a range from 1 cycleper degree to 180 cycles per degree or from 1 cycle per degree to 30cycles per degree or from 1 cycle per degree to 10 cycles per degree,and a contrast within a range 99.9% to 2.5%, for example. The projectedimage can be projected on to the retina with an eccentricity in relationto the fovea, and the eccentricity can be within a range from 5 degreesto 40 degrees. The projected image may cover the whole retina within thespecified range of eccentricity, for example with an annular pattern, orthe projected image may cover a portion of the retina within the rangeof eccentricity. The stimulation may be continuous or periodic oraperiodic. When periodic, the stimulation may persist for a durationwithin a range 1 sec to 24 hours. The stimulation may be applied in manyways, for example when the subject is awake or asleep and combinationsthereof. The retinal stimulation may be applied using a light projectionsystem. The light projection system can be configured in many ways andis suitable for combination with one or more of many devices. Theprojection optics as described herein can be integrated into one or moreof a projector, an ophthalmic equipment, a TV screen, a computer screen,a handheld device such as a smart phone, a wearable device such as aspectacle lens, a near eye display, a head-mounted display, a goggle, acontact lens, a corneal onlay, a corneal inlay, a corneal prosthesis, oran intraocular lens. For example, the projection optics can be combinedwith a combination of these devices.

In some embodiments, a device to simulate the retina comprises a lightsource and optics to form an image in front of the retina, behind theretina or on the retina with one or more of an appropriate resolution,depth of focus or diffraction. The image formed on a region of theretina may comprise a resolution finer than the resolution of the retinaat the region, such as the highest resolution of the retina at theregion. The light beam can be directed to the region of the retina at anangle relative to the optical axis of the eye, so as to illuminate anouter portion of the retina away from the fovea with a resolution finerthan the corresponding location of the retina. The depth of focus can beconfigured to illuminate the retina with an appropriate amount ofblurring of the image on the retina, and the diffraction of the spot canbe appropriately sized to provide resolution of the image formed infront of the retina finer than the resolution of the retina.

In accordance with some embodiments, a device to stimulate the retinacomprises micro-displays located away from a center of a lens and towarda periphery of the lens, in which each of the micro-displays is coupledto a micro-lens array located posteriorly to the micro-display. Themicro-displays may comprise an OLED (organic light emitting diode) or anarray of micro-LEDs. The micro-lens arrays can be optically coupled withthe displays to efficiently collect light from the micro-displays, andsubstantially collimate the light and/or converge the light beforeprojecting the light into the entrance pupil. The images created bythese displays can be myopically or hyperopically defocused and placedsymmetrically in a plurality of regions on the retina, such as foursectors (nasal-inferior, nasal-superior, temporal-inferior andtemporal-superior). The micro displays can be located away from theoptical center of the lens by a distance within a range from 1.5 mm to4.0 mm, such as 2.5 mm to 3.5 mm. The central optical zone 14 of thelens can be configured to provide emmetropic vision for the wearer, andmay have a diameter within a range 3.0 to 5.0 mm. Each micro-display cangenerate a retinal image with an appropriate shape, such as circular orarcuate and at an angle of about 20 to 60 degrees with respect to thefovea. In some embodiments, the retinal images are formed at theperipheral retina at an eccentricity in the range of 7.5 degrees toabout 45 degrees or 15 degrees to about 45 degrees or 15 degrees to 40degrees, for example within a range from 15 to 30 degrees, 20 to 30degrees, or 25 to 30 degrees. The lens may comprise an electroniccontrol system mounted with the micro-displays on a flexible transparentsheet of material such as plastic and other components.

In some embodiments, the micro displays comprise OLEDs with pixel sizeswithin a range from 2.0 micrometers (microns) to 5.0 microns, with apitch within the range of 3.0 microns to 10.0 microns. In someembodiments, the micro displays comprise OLEDs with pixel sizes within arange from 5.0 micrometers (microns) to 50.0 microns, with a pitchwithin the range of 10.0 microns to 100.0 microns. In some embodiments,the micro-displays embedded in the lens comprise micro-LEDS illuminatingan object, such as a thin film placed in front of it and toward the eye.The film may be transparent or translucent comprising a printed patternthat may be a Fourier transform of the image designed to be projected onthe retina. The micro-displays may comprise polychromatic ormonochromatic micro-displays. The polychromatic images can be formed byRGB pixels in the OLED or micro-LEDS of different colors, organized inarrays so as to form an RGB display. In some embodiments, the wavelengthfor stimulation of the retain is within a range from about 450 nm toabout 560 nm (in some embodiments, from about 410 nm to about 560 nm),and can be near 500 nm, the peak wavelength of stimulation of rods inthe eye, although other wavelengths may be used. In some embodiments,the chromaticity of the light sources includes violet light comprising awavelength within the range from 400 to 450 nm.

In some embodiments, an optical configuration comprises one or morelight sources coupled to one or more projection optics that comprise oneor more of a collimating lens, a compound lens such as a Gabor lens, aprism, an array of prisms, a mirror, a lightguide, a waveguide, aplurality of mirrors, or holographic mirrors. In some embodiments, thewaveguide is configured to preserve a phase of the wavefront transmittedtherethrough. The one or more projection optics can be configured toimage the one or more light sources so as to a project an image of thelight source in front of, behind, or on the peripheral retina. In someembodiments, the optic configuration is placed at or near the anteriorsurface of the lens, and rays from the micro-displays are focused by thelens. In some embodiments, the lens is configured to provide refractivecorrection to the wearer, and the display optics configured to provideadditional focus to provide the defocused image of the micro-display onthe retina. In some embodiments, the amount defocus is in within a rangefrom about 2.00 Diopter (D) to 6.00 D, and can be within a range fromabout 2.0 D to 4.0 D.

In some embodiments, a spectacle lens is configured with a near eyedisplay that projects a 2.0 to 5.0 D or 2.0 to 7.0 D myopicallydefocused image at the outer retina toward the retinal periphery, whilemaintaining central vision. In some embodiments, a device comprises pairof spectacle lenses is configured with near eye displays that project apair of 2.0 to 5.0 D or 2.0 to 7.0 D myopically defocused images at theretinal periphery, while maintaining central vision. Each optic of thedevice may be coupled to a near eye display to project the one or moremyopically defocused images at the retinal periphery while the opticalcenter of the spectacle lens optic provides the required refractivecorrection to the wearer for far vision. The optic can be configured toprovide the refractive correction in order to allow comfortable andclear viewing of the real world at all object distances, while thedisplay projects the 2.0 to 5.0 D or 2.0 to 7.0 D myopically defocusedimages toward an outer portion of the retina.

In some embodiments, a spectacle lens is configured to projectmyopically defocused images at the retinal periphery while maintaininggood focus at the central retina. In some embodiments, a spectacle lensis configured to provide a light field, in which the refractive power ofthe lens varies with the gaze direction and object distance across thebody of the spectacle lens optic. In some embodiments, the spectaclelens is configured to provide a match between vergence, imagemagnification and refractive correction. In some embodiments, nearvision is usually associated with a lower gaze angle (inferior gaze),and the refractive power of a multifocal or progressive additionspectacle lens optic increases downwards. In some embodiments, thespectacle is configured for a wearer who can accommodate the spectacleprovides less plus power. Additionally, the optical design of abinocular optic may be adjusted to promote binocular summation whileexecuting conjugate eye movements. In some embodiments, the area of thespectacle lens optic that is left unmodified is an area approximately 8to 15 mm, preferably 10 to 12 mm in diameter disposed around the opticalcenter of the spectacle lens optic. In some embodiments, the area of thespectacle lens optic that is left unmodified is an area preferably 10 to15 mm in diameter disposed around the optical center of the spectaclelens optic.

In some embodiments, the near eye display comprises a microminiaturelight source, such as an organic light emitting diode (“OLED”), atransparent organic LED (“TOLED”) or an i-LED, and a micro-lens array tosubstantially collimate the light emanating from the light source anddirect it to the pupil of the eye. Alternatively or in combination, amicro-mirror array can be used to collimate the light emanating from thelight source and direct it to the pupil of the eye. In some embodiments,the light source is mounted on a transparent substrate (e.g., a TOLED),while in some embodiments, it may be mounted on an opaque substrate,such as silicon. The light source may comprise an active matrix or apassive matrix. The components can be held together in a transparenthermetically sealed package. In some embodiments, the hermetic sealingpackage may be conformal, comprising a multilayer film of totalthickness within a range from 5 microns to 25 microns, for example from10 microns to 15 microns. The device can also include a component thatcan monitor eye movements such as a gaze tracker. In some embodiments, agaze tracker is configured to locate the point on the spectacle lensoptic corresponding to the point of regard, at which the optic axis ofthe eye intersects the optic for a particular position of the eye as theeye executes pursuit eye movement such as tracking of a moving object.In some embodiments, eye movement may be monitored and followed by aneye tracker which may comprise a coil embedded in the eyeglass framethat senses movement of the eye through the development of a transientmagnetic field during eye movement, for example from movement of a coilsuch as a coil within a contact lens worn on the eye. In someembodiments, retinal images formed by the light rays from the displayare myopically defocused by 2.0 D to 5.0 D or 2.0 to 7.0 D anteriorly tothe retina and are incident on the outer portions of the retina so as toform images anteriorly to the retina. While the images can be formedanteriorly to the retina in many ways, in some embodiments the imagesare formed about 15 degrees to 40 degrees eccentric to the fovea. Insome embodiments the images are formed about 5 degrees to 40 degreeseccentric to the fovea.

BRIEF DESCRIPTION OF THE DRAWINGS

A better understanding of the features, advantages and principles of thepresent disclosure will be obtained by reference to the followingdetailed description that sets forth illustrative embodiments, and theaccompanying drawings of which:

FIG. 1 shows a soft contact lens, in accordance with some embodiments;

FIGS. 1A and 1B show spectacles suitable for incorporation with thepresent disclosure, in accordance with some embodiments;

FIG. 2A shows OLED micro displays embedded into a soft contact lens,optically coupled with micro lens arrays for projecting images withmyopic defocus on the periphery of the retina of a wearer, in accordancewith some embodiments;

FIG. 2B shows a soft contact lens comprising a plurality of lightsources and optics and associated circuitry, in accordance with someembodiments;

FIG. 2C shows a system diagram of the function of the components of thecontact lens as in FIG. 2B;

FIG. 3 shows an optical configuration in which the optical path lengthis increased by folding back the optical path using two mirrors, inaccordance with some embodiments;

FIG. 4 shows a ray tracing simulation of the optical configuration shownin FIG. 3, in which the Liou Brennan eye model has been used to computethe retinal image, in accordance with some embodiments;

FIGS. 5A and 5B show analysis of retinal image quality generated by theoptic configuration of FIG. 3;

FIG. 6 shows analysis of depth of focus of the optic configuration shownin FIG. 3;

FIG. 7 shows the MTF for the analysis of FIG. 6.

FIGS. 8A and 8B show an optical configuration comprising a lens to focuslight onto the retina, in accordance with some embodiments;

FIG. 9 shows analysis of retinal image quality generated by the opticconfiguration shown in FIGS. 8 and 8B, in accordance with someembodiments;

FIG. 10 shows analysis of depth of focus of the optic configurationshown in FIGS. 8A and 8B.

FIGS. 11A and 11B show a light-pipe in order to increase the opticalpath length, in accordance with some embodiments;

FIG. 12 shows soft contact lens with embedded light sources, optics andelectronics, in accordance with some embodiments;

FIG. 13 shows a ray tracing simulation of the peripheral retinal imageformed by a combination of a microscopic light source and a micro-optic,in accordance with some embodiments;

FIG. 14 shows four object points used to simulate image quality usingray tracing for a light source comprising four simulated object points,in accordance with some embodiments;

FIG. 15 shows the quality of a peripheral image generated by areflective optic, in which Modulation transfer functions (MTF) of allthe object points are substantially coincident, in accordance with someembodiments;

FIG. 16 shows depth of focus of the peripheral image formed by thereflective optic, in accordance with some embodiments;

FIG. 17 shows the effect of myopic blur on image resolution of theperipheral retinal image formed by the reflective optic, as measured bychange of the magnitude of MTF at a single spatial frequency (20/200 or10 line pair per mm “lp/mm” or 10 arc min) as a function of themagnitude of myopic defocus for the reflective optical design, inaccordance with some embodiments;

FIG. 18 shows MTF plots of the retinal image formed by the refractiveoptic for the four object points shown in FIG. 14, in accordance withsome embodiments;

FIG. 19 shows depth of focus of the image formed by the refractiveoptic, in accordance with some embodiments;

FIG. 20 shows MTF computed for a single spatial frequency (20/200 or 10lp/mm, or 10 arc min) as a function of myopic defocus, in accordancewith some embodiments;

FIG. 21 shows MTF plots of the four object points in FIG. 14 forembodiments comprising a miniature lightguide, in which a substantialdifference in image quality exists between sagittal and tangentialplanes, indicating non-symmetrical aberrations, in accordance with someembodiments;

FIG. 22. Depth of focus of the peripheral retinal image projected by thelightguide optic, in accordance with some embodiments;

FIG. 23 shows MTF plots at a single spatial frequency (20/200) plottedagainst the magnitude of myopic defocus of the peripheral image on theretina for embodiments with light guides;

FIG. 24 shows a comparison of depths of focus of the peripheral imagesgenerated by the three projection systems, comprising a refractiveoptic, a reflective optic and a lightguide optic, in accordance withsome embodiments;

FIG. 25 shows depth of focus of the retinal image generated by areflective optic design, in accordance with some embodiments and

FIG. 26 shows MTF values at a single spatial frequency plotted againstmagnitude of myopic defocus for the peripheral image created by thereflective optic design of FIG. 25, in accordance with some embodiments.

DETAILED DESCRIPTION

The presently disclosed methods and apparatus can be configured in manyways to provide retinal stimulation as described herein. The presentlydisclosed methods and apparatus are well suited for combination withmany prior devices such as, one or more of an ophthalmic device, a TVscreen, a computer screen, a handheld, a mobile computing device, atablet computing device, a smart phone, a wearable device, a spectaclelens frame, a spectacle lens, a near eye display, a head-mounteddisplay, a goggle, a contact lens, an implantable device, a cornealonlay, a corneal inlay, a corneal prosthesis, or an intraocular lens.Although specific reference is made to spectacles and contact lenses,the presently disclosed methods and apparatus are well suited for usewith any of the aforementioned devices, and a person of ordinary skillin the art will readily appreciate how one or more of the presentlydisclosed components can be interchanged among devices, based on theteachings provided herein. For example, although specific reference ismade to a contact lens with projection optics, light sources andcircuitry to stimulate the retina away from the fovea, the projectionoptics, light sources and circuitry can be incorporated into one or moreof an ophthalmic device, a TV screen, a computer screen, a handheld, amobile computing device, a tablet computing device, a smart phone, awearable device, a spectacle lens frame, a spectacle lens, a near eyedisplay, a head-mounted display, a goggle, a contact lens, animplantable device, a corneal onlay, a corneal inlay, a cornealprosthesis, or an intraocular lens, in order to provide retinalsimulation as disclosed herein.

The methods and apparatus for retinal stimulation as described hereincan be configured in many ways and may comprise one or more attributesto encourage a user to receive therapy. For example, the retinalstimulation as described herein can be combined with a display of a gameto encourage a user to wear the treatment device. In some embodiments,the retinal stimulation can be combined with another stimulus, such asan emoji, to encourage a user to wear the device for treatment.

The retinal stimulation device may comprise global positioning system(GPS) circuitry for determining the location of the wearer, and anaccelerometer to measure body movement such as head movement. Theretinal stimulation device may comprise a processor coupled to one ormore of the GPS or the accelerometer to receive and store measured data.The retinal stimulation device may comprise communication circuitry suchas wireless communication circuitry, e.g. Bluetooth or WiFi, or wiredcommunication circuitry, e.g. a USB, in order to transmit data from thedevice to a remote server, such as a cloud based data storage system.This transmission of data to the remote server can allow the treatmentand compliance of the wearer to be monitored remotely. In someembodiments, the processor comprises a graphics processing unit (GPU).The GPU can be used to efficiently and rapidly process content from theweb in order to utilize this content in forming the stimulus asdescribed herein.

In some embodiments, the device comprises one or more cameras that arecapable of capturing still images or video images of the real worldscenery that may be used to form the stimulus signal.

In some embodiments, one or more projection optics is configured toproject a defocused image on the retina away from the central field thatincludes the macula in order to stimulate an increase in choroidalthickness. In some embodiments, one or more projection optics isconfigured to project a defocused image on the retina away from thecentral field that includes the macula in order to stimulate a transientincrease in choroidal thickness. The one or more projection optics canbe configured to stimulate the retina without degrading central visionand corresponding images formed on one or more of the foveal or macularregions of the retina. In some embodiments, the one or more projectionoptics do not decrease the image forming characteristics of the visioncorrection optics prescribed to correct refractive errors of thewearers. The correction optics may comprise one or more of contactlenses, spectacle lenses, intraocular lenses, corneal onlays or cornealinlays. The one or more projection optic can be coupled to one or morelight sources to illuminate the retina with one or more defocusedimages. In some embodiments, the one or more light sources comprises anoptical display such as a micro-optical display, and the one or moreprojection optics comprises a micro-optical array. The components can bemounted on a flexible printed circuit board (“PCB”) substrate to supportthe electronic and optical components. In some embodiments, themicro-display is optically coupled to a micro-optical array thatsubstantially collimates and focuses the light emanating from themicro-display. The micro-display may comprise miniaturized pixels eachwith a size within a range from 2 microns to 100 microns. Themicro-display can be coupled to and supported with the body of thecorrection optic such as a contact lens, or a spectacle lens, forexample. In some embodiments, the micro-displays are coupled to andsupported with one or more of an intraocular lens, a corneal prosthesis,a corneal onlay, or a corneal inlay. The optical configurationsdescribed herein with reference to a contact lens can be similarly usedwith one or more of an intraocular lens, a corneal prosthesis, a cornealonlay, or a corneal inlay, for example.

In some embodiments, one or more projection optics is coupled to andsupported with a pair of spectacles. For example, the projection opticscan be coupled to the outer surface or embedded in a pair of spectaclelenses. In some embodiments, the projection optics comprise apico-projector mounted on the temples of an eyeglass frame. In someembodiments, the projection optics are optically coupled with one ormore optical fibers that deliver the projected image to an eyeglassoptics and be directed to the pupil of the eye, for example with apartially transmitting mirror. In these embodiments, an eye tracker canbe configured to monitor eye movements so that the activation of thepixels in the micro-display can be programmed to compensate for the eyemovement recorded by the eye tracker. In some embodiments, the eyetracker comprises a search coil mounted in the inner surface of theframe of the spectacle lens. The search coil can be configured in manyways to detect eye movement. In some embodiments, the subject is fittedwith a contact lens to provide refractive correction for the eye of thesubject. A metallic wire or magnetic material is embedded into thecontact lens that creates a magnetic field in the search coil when eyemovement occurs. In some embodiments, the magnetic field is analyzedwith a processor to determine the start and stop point of the eye, andthe time taken to execute the eye movement. In some embodiments themicro-display and the circuitry coupled to the display are configured torespond to the eye movement and selectively activate a differentplurality of pixels in response to the eye movement within anappropriate time. The time to selectively switch to a second pluralityof pixels in response to the eye movement can be less than 100milliseconds, for example less than 20 milliseconds.

In some embodiments, the micro-displays and the micro-optic arrays aremounted immediately adjacent to each other on the same correction optic,separated by a fixed distance in order to project a bundle of rays tothe pupil of the eye, at an orientation that it forms a myopicallydefocused image at a desired location on the retina as described herein.In some embodiments, the one or more projection optics is mounted on orin the one or more correction optics, such that rays from the projectionoptics are refracted through the correction optics. The correctionoptics refract the rays from the projection optics to be convergent ordivergent as helpful for emmetropia, so that the micro-optical array canprovide the desired magnitude of additional power that may be plus orminus, depending on the magnitude and sign of the defocus desired. Themicro-display may be monochromatic or polychromatic, for example. Themicro-display may have a luminance within a range from 1 nit to 10,000nits or 10 nits to 1000 nits, or from 100 lux to 5,000 lux, for example.In some embodiments the micro-display may have a luminance within arange from 100 nits to 50000 nits, or from 50 lux to 5,000 lux, forexample. In some embodiments, the micro-display is positionedeccentrically with respect to the optical center of the correctionoptic, at distances within a range from 1.0 mm to 4.0 mm from the centerof the correction optic. In some embodiments, the micro-display forms anextended array of pixels, characterized by a pixel size and a pixelpitch, in which the pixel size and the pixel pitch together correspondto a fill factor of the micro-display. As described herein, pixel sizesmay range from 2 microns to 100 microns, and the pixel pitch may rangefrom 10 microns to 1.0 mm, for example. The corresponding fill factorcan range from 0.1% to 10%. In some embodiments, the pixel array isoptically coupled with a micro-optic array in order to substantiallycollimate and focus light from the pixels. In some embodiments, a layerof the micro-display and a layer of micro-optic array are encapsulatedin a substantially transparent medium configured to decrease lightscatter. The encapsulated image delivery system comprising the one ormore light sources and the one or more projection optics may besubsequently coated with a conformal, hermetically sealing transparentmultilayer coating, for example.

In some embodiments, the micro-display may be mounted on a correctionoptic such as a spectacle lens while the micro-optic array may bemounted on a second correction optic such as a contact lens, a cornealonlay or a corneal inlay. Alternately or in combination, an augmentedreality (AR) or a virtual reality (VR) display may be used to projectthe defocused image on the retina. The AR or VR device can be mounted onan eyeglass frame, a goggle, or a head mounted display. Refractivecorrection may be provided by a spectacle lens or a contact lens, whileoptics coupled to the micro-optic array of the AR or the VR deviceprovides the defocus.

In some embodiments, the projected defocused image can be provided by ascreen comprising one or more of an LCD screen, a screen driven by OLEDS(organic light emitting diodes), TOLEDS, AMOLEDS, PMOLEDS, or QLEDS. Thescreen may be appear to the subject at a far distance of east least 6meters or more, for example.

The stimulation can be configured in many ways and may comprisemonocular stimulation or binocular stimulation.

The micro-optic array can be configured in many ways and may compriseone or more of an array of lenslets, an array of compound lenses, suchas Gabor lenses, one or more mirrors, prisms, a lightpipe or a lightguide, or a waveguide.

In some embodiments, the projected image comprises image structurecontent configured to provide a range of spatial frequencies, forexample within a range from 2 cycles per degree to about 60 cycles perdegree. In some embodiments, the projected image comprises imagestructure content configured to provide a range of spatial frequenciesbetween 2 cycles per degree and about 30 cycles per degree. Work inrelation to the present disclosure suggests that the capability of theperipheral retina to detect blur is higher than its ability to resolveimages. The size and shape of the projected image may within a rangefrom 100 microns to 2.5 mm, subtending a range of angles with respect tothe fovea from 15 degrees to 360 degrees or from 5 degrees to 360degrees, for example. The location of the image may be within a rangefrom 5 degrees to 30 degrees eccentric to the fovea, for example withina range from 12 degrees to 30 degrees. Alternatively, the projectedimage may cover the whole retina for a pan-retinal treatment of defocus.

In some embodiments, the brightness of the projected image is within arange from 1 Troland to 250 Trolands. In some embodiments, the imagebrightness is adjustable based on the brightness of ambientillumination. The range of contrast of the projected image can be withina range from 99.9% to 2.5%, for example within a range of 99.9% to 10%.

Projection of the defocused image as described herein may be sustainedover any appropriate amount of time, for example over a substantial partof a day (e.g. 8 hours or more), and the stimulation may be repeatedevery day at approximately the same time, so as to not to disturbcircadian rhythms. The projected image may have a duration as short as15 minutes, repeated throughout the day at hourly intervals, forexample. The projected image may be continuous over a time within arange from 15 minutes to 12 hours per day. The stimulation may beprovided over periods of 1 day to 3 years or as long as treatment isbeneficial.

In accordance with some embodiments, a soft contact lens comprisesperipheral micro-displays, each of which is fronted eye side by amicro-lens array. The micro-displays may comprise an OLED (organic lightemitting diode) or an array of micro-LEDs. Light emitted by thesedisplays is typically Lambertian. The micro-lens arrays are opticallycoupled with the displays, so that they can efficiently extract lightfrom the micro-displays, collimate the light and focus it beforeprojecting them into the entrance pupil. The virtual images created bythese displays will be myopically defocused and will be placedsymmetrically in the four sectors (nasal-inferior, nasal-superior,temporal-inferior and temporal-superior), in some embodiments. The microdisplays will be located away from the optical center of the lens by adistance within a range from 1.5 mm to 4.0 mm, preferably 2.5 mm to 3.5mm, in some embodiments. The central optic of the contact lens can beselected to bring the wearer as close to emmetropia as possible, and mayhave a diameter within a range 3.0 to 5.0 mm. Each micro-display will becircular, rectangular or arcuate in shape and will each have an areawithin a range from 0.01 mm² to 8.0 mm², for example within a range from0.04 mm² to 8.0 mm², for example within a range from 1 mm² to 8 mm², orpreferably within a range from 1.0 mm² to 4.0 mm², in some embodiments.In some embodiments, each of the plurality of micro-displays comprisesthe light source, the back plane and associated electronics with thedimensions and shapes as described herein. The contact lens will have anelectronic control system as well as the micro-displays mounted on aflexible transparent sheet of plastic. The electronic system maycomprise an ASIC or a microcontroller, a rechargeable Lithium ion solidstate battery, a voltage ramping module e.g., a buck boost converter, aflash memory and an EEPROM, an RFID module to provide wirelessrecharging, or an antenna preferably disposed radially along the edge ofthe contact lens, and any combination thereof. The contact lenscomprises a biocompatible material, such as a soft hydrogel or siliconehydrogel material, and may comprise any material composition that hasproven to be compatible with sustained wear on the eye as a contactlens.

In some embodiments, virtual images focused at a target distance fromthe peripheral retina, equivalent to a myopic defocus. Rays formingthese images do not come from outside environment but from themicro-displays themselves, so the optics of the micro-lens arrays can besolely designed to process the rays emanating from the micro-displays.The area of each of these micro-displays and micro-lens arrays in frontof each is small, so the obscuration of the real image is small, asshown in FIGS. 1 and 2.

The device as described herein can give each caregiver substantialflexibility in setting and testing such parameters for an individualpatient, then refining the preferred parameters of treatment based onobservations of patient response.

Some embodiments comprise a contact lens of diameter 14.0 mm, with anedge zone of 1.0 mm and a peripheral zone 16 whose inner diameter is 6.0mm and outer diameter is 12.0 mm. The overall diameter of the lens maybe in the range of 13.0 mm and 14.5 mm, preferably 13.5 and 14.5 mm. Thecentral optical zone 14 is designed to cover the pupil of all wearersunder all illumination conditions, and should therefore have a diameterin the range of 5.0 mm and 8.0 mm. The peripheral or the blend zone isprimarily designed to provide a good fit to the cornea, including goodcentration and minimum decentration. The central optical zone 14 isdesigned to provide emmetropic correction to the wearer and may beprovided with both spherical and astigmatic correction (FIG. 1). Contactlens designs suitable for incorporation in accordance with embodimentsdisclosed herein are described in Douthwaite, D. A., “Contact lensoptics and lens design”, 3^(rd) edition, 2006; ISBN 978-0-7506-88-79-6;Butterworth-Heinemann.

In some embodiments, the inner surface of the contact lens is embeddedwith a set of four micro-displays coupled eye side with micro-lensarrays of the same size. The function of the micro-lens arrays is tocollimate the light being emitted by the micro-displays, collimate it,and focus it at a focus that is designed to be in the front of the eye,to provide hyperopic defocus. The micro-displays can be sized in manyways, and each of these micro-displays is only about 0.04 mm² to 2 mm²in area, for example from 1 mm² to 2 mm² in area, so that these displayscover less than 1% of the contact lens optic, in some embodiments. Eachof the displays will generate about 30-50 cd/m² or greater ofillumination, quite sufficient for forming a relatively bright image atthe focus of each of these micro-displays. The focused images willappear approximately 1.5-2.5 mm in front of the peripheral retina, sincethey will be designed to be myopic by about 2.0 D to 5.0 D, for example2.0 D to 4.0 D, or preferably 2.5 D to 3.5 D, for example.

In some embodiments, the micro displays may be OLEDs with pixel size of2.0 microns to 5.0 microns, with a pitch in the range of 2.0 microns to10.0 microns. In some embodiments, the micro-displays embedded in thecontact lens as described herein will consist of micro-LEDS illuminatingan object, such as a thin film placed in front of it, eye side. Themicro-displays may be polychromatic or they may be monochromatic. Thepolychromatic images are formed by RGB pixels in the OLED or micro-LEDSof different colors, organized in arrays so as to form an RGB display.Data on wavelength dependence of axial length alteration of theprojected hyperopic or myopic image at the peripheral retina arelacking. A preferred wavelength for stimulation of change in axiallength is 500 nm, the peak wavelength of stimulation of rods in the eye,although other wavelengths may be used.

The amounts and location of illumination on outer locations of theretina to provide a therapeutic benefit can be determined by one ofordinary skill in the art without undue experimentation in accordancewith the teachings disclosed herein. The length and duration ofperipheral stimulation can be determined, for example optimized, basedon available preclinical data in animal models. For example, somestudies suggest that changes in axial length in animal models can beobtained on repeated application of defocus stimuli, in preference to asingle sustained period of equivalent duration of imposed defocus.Examples of studies with information on illumination changes in axiallength suitable for incorporation in accordance with the embodimentsdisclosed herein include: Wallman, J., et al, “Homeostatis of eye growthand the question of myopia”, in Neuron, 2004; 43: pp 447;Benavente-Perez, A, et al, “Axial Eye Growth and Refractive ErrorDevelopment Can Be Modified by Exposing the Peripheral Retina toRelative Myopic or Hyperopic Defocus” In IOVS 2014; 55: pp 6767; andHammond, D. S., et al, “Dynamics of active emmetropisation in youngchicks—influence of sign and magnitude of imposed defocus” in OphthalmicPhysiol Opt. 2013; 33: pp 215-222.

Work in relation to the present disclosure suggests that the durationand distribution of application of peripheral myopic defocus will dependon individual physiology and the precise shape of the retina. Anembodiment comprises a reprogrammable MCU or ASIC controlling theoperation of the micro-displays, and a real time clock that will enableadjustment of the treatment duration and periodicity by the caregiver,throughout the treatment. This embodiment also enables the caregiver totest whether nocturnal stimulation (sustained or repeated sequence ofshort pulses) has an efficacy for certain individuals.

In some embodiments, the electronic components are populated on aflexible thin film on which interconnects and electrical bus aredeposited by means of vapor deposition or a 3D printing process. In someembodiments, the electronics and the micro-displays are further coatedwith a flexible stack of thin barrier film, such as a stack of ParalyneC and SiO_(x) film of total thickness 5-10 microns, developed by Coat-X,a corporation located in Neuchatel, Switzerland.

Some embodiments of the device deploy a set of one to eightmicro-displays, each circular or arcuate in shape, and they are disposedradially on the inner surface of the contact lens, all at the samedistance from the optical center of the lens. In one embodiment, theymay be monochromatic. In another embodiment they may be designed toprovide white light output. In a third embodiment, they may be designedto output illumination matched to the retinal sensitivity. Thesemicro-displays are operated and controlled by a reprogrammablemicrocontroller (MCU) or an ASIC.

In some embodiments, the contact lens is worn during sleep, and themicro-displays are programmed to operate only when the wearer is asleep.Such a programmed stimulation of reduction of the axial length willinterfere minimally with daily activities, including reading andcomputer work. The contact lens may even be removed during daytimeactivities, while it is fit on the cornea just before going to sleep.Other embodiments may utilize other programming algorithms, for examplea combination of daytime and nighttime stimulations.

In some embodiments, the contact lens may be a daily disposable lens,obviating the need for disinfecting and cleaning the lens or rechargingit. Another embodiment consists of a contact lens of planned replacementmodality.

In some embodiments, each micro-display (1 mm² to 4 mm²) will consumeabout 10 microwatts of electrical energy. In these embodiments, a set offour micro-displays may use about 125 microwatt-hours of electricity for2 hours of operation, so that the total daily energy consumption forthis design will be expected to be 0.2 milliwatt-hour. In someembodiments, each micro-display comprises a cross-sectional area withina range from about 0.04 mm² to 4 mm² and consumes about 10 microwatts ofelectrical energy. In some embodiments, the electrical power is suppliedby a rechargeable, solid state lithium ion battery. A bare die solidstate rechargeable lithium ion battery, marketed by Cymbet Corporation,may be populated on the same flexible substrate as the electronics ofthe lens. For example, a 50 uAH rechargeable lithium ion solid filmbattery has dimensions of 5.7×6.1 mm×0.200 mm (Cymbet CorporationCBC050). In some embodiments, the battery comprises sufficient mass tostabilize the contact lens. For example, the battery can be located onan inferior position of the lens in order to stabilize the lens withgravity. The inferiorly located battery may comprise a mass sufficientto decrease rotational movement such as spinning when the wearer blinks.

In some embodiments, an electronic contact lens projects a 2.0 to 5.0 Dor 2.0 to 7.0 D myopically defocused image at the retinal periphery,while maintaining excellent vision at the center.

In some embodiments, the electronic soft contact lens comprisesmicroscopic light sources and microscale optics embedded at theperiphery of the lens optic. The contact lens optic can be designed toprovide excellent vision at the central retina, while the outer lightsources project images at the outer portions of the retina that aremyopically defocused. In some embodiments, the light sources comprisemicro displays. In some embodiments, the outer images formed anterior tothe retina may to stimulate the retina to move forward, reducing theaxial length and deepening the vitreous compartment. In some embodimentsthe contact lens is configured to one or more of decrease myopiaprogression, substantially stop myopia progression, or reverse myopia inthe eye wearing the lens. In some embodiments, the contact lens can beconfigured for extended wear and replaced once a month, for example. Thecontact lens can be replaced more frequently or less frequently, forexample, once a week, or once every three months. In some embodiments,the contact lens is designed to be worn by teens and young adults, whocan be at greater risk of myopia progression than people of other ages.

In some embodiments, the amount of myopic defocus of the peripheralimage is within a range from about or 2.0 D to about 7.0 D, for examplefrom 2.0 D to about 5.0 D or from about 2.5 D to about 5 D. Based on theteachings disclosed herein a person of ordinary skill in the art canconduct studies such as clinical studies to determine appropriateamounts of defocus, illumination intensities and times of illumination.In some embodiments, one or more of the amount of defocus, the retinallocations of the retinal illumination or the times of illumination canbe customized to an individual, for example in response to physiologicalcharacteristics of the individual patient. The duration of treatment canbe within a range from 1 to 3 years, for example about 2 years. In someembodiments, the treatment is performed with a number of lenses within arange from about 10 lenses to about 40 lenses, for example from about 10lenses to about 30 lenses. The prescription of the optical zone 14comprising the central lens optic may change with time during treatment,and the prescription of the contact lens can be changed is appropriate.The contact lenses as disclosed herein may also be subsequently worn asneeded, for example if myopia progression returns.

The electronic contact lens can be configured in many ways to correctrefractive error of the wearer. In some embodiments, the contact lenscomprises a plurality of micro-displays that emit light near a peripheryof the optical zone 14 of the contact lens, a plurality of micro-opticsto collect, collimate and focus the light rays emanating from the lightsources, a miniaturized rechargeable solid state battery to providepower to the light sources (e.g. a Lithium ion solid state battery), anantenna to wirelessly receive power to recharge the battery, and amicro-controller to control actuating and controlling functions, and amemory to store data or software instructions.

In some embodiments, the outer image comprises a peripheral imagelocated outside the macula, for example within a range from about 20degrees to about 30 degrees eccentric to the fovea.

The contact lens can be configured in many ways with a plurality ofoptics such as micro-optics to collect light from a plurality of lightsources (e.g. microscope light sources) and form an image anterior to anouter portion of the retina such as anterior to a peripheral portion ofthe retina. In some embodiments, the plurality of optics comprises oneor more of a light-pipe and a reflective component, such as mirrors, forexample microscopic mirrors.

The device as described herein can be used to treat advancement ofrefractive error such as myopia. In some embodiments, each caregiver hassubstantial flexibility in setting and testing parameters for anindividual patient, then refining the preferred parameters of treatmentbased on observations of patient response.

In some embodiments, the optical design of the refractive properties ofthe contact lens substantially unaltered and can be configured in manyways. For example, the central optical zone 14 of the contact lens canbe optimized for best correction of the far image at the fovea, whileproviding images at the periphery of the retina that are anterior to theimage shell of the contact lens optic, so as to decrease the advancementof refractive error. In some embodiments, the light sources may comprisea surface area of no more than 2 mm² of the optical surface, and thesize of the optical surface to correct refractive error can be within arange from about 25 mm² to about 50 mm², which can decrease the effectof the light source on vision. An intensity of the peripheral image thatcan be provided independently of the level of ambient illumination, andthe intensity of the light sources can be adjusted over several ordersof magnitude by selecting light sources of appropriate power. The softcontact lens can be configured to provide appropriate amounts ofillumination response to input from the wearer or a health careprovider.

FIG. 1 shows micro-displays 12 embedded in a lens as described herein,such as a contact lens 10. Although reference is made to a contact lens,the lens 10 may comprise a lens of one or more of a projector, anophthalmic equipment, a TV screen, a computer screen, a handheld devicesuch as a smart phone, a wearable device such as a spectacle lens, anear eye display, a head-mounted display, a goggle, a contact lens, acorneal onlay, a corneal inlay, a corneal prosthesis, or an intraocularlens.

The soft contact lens 10 comprises an optical zone 14 configured toprovide far vision correction to the wearer, for example with a visualacuity of 20/20 or better. The optical zone 14 may comprise a distanceacross such as a diameter or a radius 15, which may comprise anysuitable size such as a radius of about 3 mm. The micro-displays 12 canbe configured to provide the images in front of the peripheral portionof the retina as described herein. This configuration can allow the userto have good visual acuity while receiving therapy from the imagesfocused in front of the retina as described herein. The micro-displays12 can be located outside the optical zone 14, or inside the opticalzone 14. Each of the micro-displays 12 may comprise a maximum distanceacross, such as a diameter 19, which can be any suitable size, forexample about 1 mm.

The micro-displays 12 may comprise micro-LEDS illuminating an object,such as a thin film placed in front of it, eye side. The light emittedby these micro-displays 12 can be Lambertian and directed to an opticalelement such as a lens to direct the light beam toward the retina. Thecontact lens 10 comprises a diameter 13 suitable for placement on aneye. For example, the contact lens 10 may comprise a diameter within arange from about 10 mm to 15 mm, for example 14.0 mm. The contact lens10 may comprise a plurality of embedded micro-displays 12. Each of theplurality of micro-display 12 can be optically coupled to an opticalconfiguration that collects light emitted by the micro-display 12 andprojects an image on or in front of the retina of the wearer at aspecified eccentricity. Each of the displays 12 can generate anillumination within a range from about 1 cd/m² to about 50 cd/m². Insome embodiments each of the displays 12 can generate an illuminationwithin a range from about 50 cd/m² to about 50000 cd/m² or from about100 cd/m² to about 50000 cd/m². The amount of illumination can besufficient for forming a relatively bright image at the focus of each ofthese micro-displays 12.

In some embodiments, the amount of illuminance is intermediate betweenphotopic and mesopic levels of illumination and intermediate levels ofsensitivity of rods and cones. In some embodiments the amount ofillumination is within a range from about 10 cd/m² to about 50000 cd/m²,such as from 100 cd/m² to about 50000 cd/m², preferably from 10 cd/m² to2000 cd/m² at the pupil plane. In some embodiments, the amount ofillumination is within a range from about 0.1 cd/m² to about 10 cd/m²,for example from 0.5 cd/m² to 5 cd/m² at the pupil plane. The amount ofilluminance may correspond to an amount of light between moonlight andindoor lighting, for example. In some embodiments, the amount ofillumination corresponds to mesopic vision.

In some embodiments, the micro-displays 12 can comprise light sourcesthat emit polychromatic light composed of light of differentwavelengths. In other embodiments, the light sources emit monochromaticlight. In some embodiments, the wavelength of the monochromaticillumination can be in the range of 500 nm to 560 nm, preferably from500 nm to 530 nm, more preferably from 500 nm to 510 nm.

In some embodiments, the polychromatic light sources provide chromaticcues to the peripheral retina. The chromatic cues may comprise negativechromatic aberration. In some embodiments, a poly chromatic light beamis focused anterior to the retina, in which the polychromatic light beamcomprises a positive chromatic aberration prior to an image plane 35 ora focal plane and a negative chromatic aberration after the image plane35 or focal plane so as to illuminate the retina with a negativechromatic aberration.

While the polychromatic illumination can be configured in many ways, insome embodiments, the polychromatic illumination comprises redillumination, blue illumination and green illumination, although otherwavelengths of light may be used.

In some embodiments, the projected images appear approximately 1.5 mm toabout 2.5 mm in front of the peripheral retina, since they will bedesigned to be myopic by about 2.0 D to 4.0 D, for example from 2.5 D to3.5 D. In some embodiments, the projected images appear approximately1.5 mm to about 2.5 mm in front of the peripheral retina, since theywill be designed to be myopic by about 2.0 D to 7.0 D, preferably 2.5 Dto 5.5 D. In general, 1 mm in front of the retina corresponds to about2.5 D of myopia, for example about 2.7 D of myopia.

This approach of peripheral stimulation of change in axial lengththrough thickening or thinning of the choroid can be based on repeatedand confirmed observations of the efficacy of application localizedhyperopic or myopic defocus in stimulating change in the axial length ofthe eye 11. The length and duration of peripheral stimulation can bebased on available preclinical data in animal models as is known to oneof ordinary skill in the art. For example, the rate of change in axiallength can obtained on repeated application of defocus stimuli, inpreference to a single sustained period of equivalent duration ofimposed defocus.

In some embodiments, the duration and distribution of application ofperipheral myopic defocus depends on individual physiology and the shapeof the retina. In some embodiments, the contact lens 10 comprises aprogrammable processor such as a microcontroller unit (MCU) orapplication specific integrated circuitry (ASIC) for controlling theoperation of the micro-displays 12. The contact lens 10 may comprise areal time clock to adjust the treatment duration and periodicity by thecaregiver, and the treatment duration and periodicity may be providedthroughout the treatment. In some embodiments, the caregiver testswhether nocturnal stimulation (sustained or repeated sequence of shortpulses) has an efficacy for certain individuals.

Spectacles for Retinal Simulation

FIGS. 1A and 1B depict spectacles 70 for the treatment of refractiveerror of the eye and suitable for incorporation in accordance with thepresent disclosure. Although reference is made to spectacles, the lightsources can be provided on any vision device described herein to treatrefractive error of the eye and to decrease myopia progression orreverse myopia, such as augmented reality (“AR) devices. A plurality oflight sources is arranged to treat myopia. The plurality of lightsources may comprise any suitable light source as described herein, suchas a micro display or projection units, for example. In someembodiments, the light sources are configured to provide illumination atthe peripheral retina in order to promote changes in choroidal andscleral tissue corresponding to different changes in axial length asdescribed herein. The lens may comprise an optical zone with opticalproperties, e.g. refractive properties, configured to treat refractiveerror of the eye and to decrease myopia progression or reverse myopia.This refractive treatment of can be combined with retinal stimulation asdescribed herein.

The spectacles 70 may comprise one or more components of commerciallyavailable augmented reality glasses, such as the ORA-2 commerciallyavailable from Optinvent (with a presence on the Internet atoptinvent.com). The spectacle 70 may comprise one or more displays 72for retinal stimulation. The near eye displays 72 may be mounted tolenses 74. The lenses 74 may be spectacle lenses supported by eyeglassframe 76. The lens 74 may be a corrective or non-corrective lens. Thelens 74 may be a plano lens, a spherical corrective lens, an astigmaticcorrection lens, or a prism correction lens. In some embodiments, thenear eye display is located away from an optical zone to provide clearcentral vision, such as of the real world over a field of view in therange of +/−2.0 degrees to +/−15.0 degrees or +/−2.0 degrees to +/−12.5degrees. An optical axis may extend along a line of sight from an objectof the patient's regard, though the lens 74 to a fovea of the eye. Insome embodiments, the spectacle 70 comprises an eye tracker suitable forincorporation in accordance with the present disclosure. The near eyedisplay 72 can be programmed to selectively activate pixels 94, in orderto provide peripheral stimulation to the retina, as described herein. Insome embodiments, a layer of a plastic substrate bearing micro-lenses isattached to the micro-display in order to generate the desired level ofdefocus and stimulation at the retina. The selectively activatablepixels can be arranged to provide an appropriate eccentricity withrespect to a line of sight of the patient, so as to provide peripheralretinal stimulation as described herein.

In some embodiments a near eye display 72 comprises a combination of amicro-display and a micro-optic. The micro-display can be placedsufficiently close to the eye so that the eye does not accommodate tofocus light rays emanating from the near eye display, even with the fullrange of natural accommodation available to the human eye. In someembodiments, the micro-optic is configured to collect, substantiallycollimate and focus the light rays emanating from the micro-display. Insome embodiments, the micro-optic is configured to form an image of thedisplay anterior to or posterior to the retina as described herein. Insome embodiments, the distance of the near eye display from the entrancepupil of the eye is within any suitable range, such as a range fromabout 10 mm to about 30 mm, or a range from about 18 mm to 25 mm, forexample at a distance of about 15 mm. The micro-display can be placed ona transparent substrate, such as the front or back surface of the lens74 of the spectacles 70. When the micro-display is placed on the frontsurface of the lens 94, then the focus of the micro-displays may beaffected by the refractive correction on the back surface of the lens94.

In some embodiments, the focus of the pixels in a micro-display may varybased on their location on the lens 74 and the refractive correctionprovided by the lens in that area. In some embodiments, the focus of thepixels may be fixed. In some embodiments, the focus of the pixels mayvary based on the sensed position of the cornea to account for therefraction of the cornea and the lens of the eye. In some embodiments,the pixels are defocused to create a defocused spot on the retina about1 mm in diameter.

Light emitted by the pixels 94 in the micro-display of the near eyedisplay can be one or more of substantially collimated or focused beforebeing directed to the pupil of the eye. In some embodiments, amicro-lens array is aligned to the pixels of the near eye display, sothat rays from the near eye display can enter the pupil and form animage anterior to or posterior to the retina. In some embodiments, thewidth of the near eye display corresponds to a patient's field of view.In some embodiments, the extent of the near eye display may besubstantially similar to the extent of the lens 74 of the spectacles 70.In some embodiments, the near eye display can be curved so that raysfrom pixels over the whole width of the display can be normal withrespect to the pupillary plane. In some embodiments, a prismatic tilt isprovided to be provided to the lenses in the micro-lens array, in orderto compensate for the tilt of the plane of the micro-display away fromthe pupillary plane.

Work in relation to the present disclosure suggests that a myopicallydefocused retinal stimulus is likely to be more effective in preventingmyopia progression when applied peripherally than when the foveal and/orthe macular image is also myopically defocused. The device can beconfigured to be worn for any suitable amount of time to provide myopiatreatment. The myopia treatment device can be worn at appropriate timesfor a treatment of two years or longer to maintain the emmetropia of thewearer or to direct the growth of the eye toward emmetropia, for exampleif the wearer has an inclination to shift to a myopic opticalconfiguration of the eye. In some embodiments, the vision correctivedevice is configured to be worn for relatively long periods for example,for several hours per day over a period of 1 month and up to 2 years,depending on the rate of myopia reversal, for example. The refractiveprescription of the central optical zone can be changed in response tothe treatment. For example, if myopia is decreased, the myopiccorrection of the central optical can be decreased. The refraction ofthe treated eye can be measured at any appropriate time period, such asmonthly, and the prescription of the central optical zone changed whenappropriate.

In some embodiments, the device provides unimpaired central vision sothat the quality of life and quality of vision of the wearers are notadversely affected. In some embodiments, central vision comprises of afield of view of +/−12.5 degrees, covering the macula, while fovealvision used for fixation has a field of view of +/−2.0 degrees. In someembodiments, central vision comprises of a field of view of +/−4.5degrees, covering the macula, while foveal vision used for fixation hasa field of view of +/−2.0 degrees. In some embodiments, the defocusedimage is projected at an outer portion of the retina toward theperiphery of the retina, for example within a range from 15 degrees to40 degrees eccentric to the fovea and can be within a range from 20degrees to 30 degrees. In some embodiments, the micro-display 72 doesnot obstruct the central vision field of view. In some embodiments, thepixels 94 do not obstruct the central vision field of view.

Alternatively or in combination with the eccentricity of the myopicallydefocused image, the device can be configured to illuminate anappropriately sized area of the image or image footprint on the retinalimage shell. Work in relation to the present disclosure suggests thatilluminating at least a portion of each of four quadrants of the retinacan be helpful. In some embodiments, each image on a quadrant of theretina occupies approximately 45 degrees of arc circumferentially. Insome embodiments, each image on a quadrant of the retina occupiesapproximately 30 degrees of arc circumferentially. Suitable amounts ofillumination at appropriate locations can provide stimulation to the eyeto remodel the choroid and ultimately the sclera and to reduce the axiallength of the eye and lead to a reduction of myopia.

The micro display and optics can be configured in many ways to provideappropriate stimulation to outer regions of the retina toward theperiphery. In some embodiments, the micro-displays and optics areconfigured to project light onto outer regions of the retinasufficiently far from the fovea, that the illumination remainssubstantially fixed even with eye movement. In some embodiments, thepoint of regard is monitored and the desired location of the pixels tobe activated on the micro-display is determined, e.g. by a computationswith a processor, such that an image is projected at the desiredlocation on the retina, allowing persistent stimulation at the sameretinal location. In some embodiments, the point of regard on thespectacle plane or the plane of the micro-display is calculated bymonitoring the horizontal, the vertical and torsional displacement ofthe eye relative to the primary position.

The point of regard can be determined with a in many ways, for examplewith an eye position sensor such as a magnetic sensor or an opticalsensor. In some embodiments, a search coil embedded in the eyeglassframe is used to track eye movements. The coil embedded in the eyeglassframe can be coupled to a magnetic structure placed on the eye, such asone or more of a coil on a contact lens, a coil implanted in the eye, amagnetic material on a contact lens, or a magnetic material implanted inthe eye. In some embodiments, the sensor comprises an optical sensor,such as a position sensitive detector or an array sensor to measure aposition of the eye optically. The optical sensor can be configured tomeasure a position of the eye in many ways, for example configured tomeasure a position of one or more of a corneal reflex from a lightsource, a pupil, a limbus or a sclera. The eyeglass frame may support anadditional light source to illuminate the eye, for example to generate acorneal reflex. Data from the sensor can provide the location of thecoaxially sighted corneal light reflex (“CSCLR”), and hence thedirection of the visual axis and the location of the fovea. The point ofregard, visual axis, optical axis, nodes of the eye, and CSCLR aredescribed in “Ocular axes and angles: time for better understanding”,Srinivasan, S., in J CATARACT REFRACT SURG—VOL 42, MARCH 2016.

In some embodiments, the near eye display comprises a transparent,flexible substrate that matches the curvature of the eyewear worn by theuser. The near eye display can be mounted on the outer side of the opticand the frame of the eyewear. The frame and the temples can be madehollow or appropriately shaped in order to accommodate the electronics,including the electronic driver of the display, the rechargeable batteryused to provide power to the system, a memory to store algorithms thatcontrol the operation of the near eye display. The device can berecharged in many ways, for example by using a micro-USB port, orwirelessly, by using a recharging module.

In some embodiments, the processor, using the eye position sensor, maybe configured to adjust the optics, such as the pixels in the microdisplay to reduce movement of the stimulated locations of the retina inresponse to eye movement. In some embodiments, target locations of theperipheral images are computed from the location of the fovea based onthe information form the eye position sensor and a real time ray tracingcalculation provides the locations of the pixels to be activated in themicro-display. The time to selectively switch to a second plurality ofpixels in response to the eye movement can be less than 100milliseconds, for example less than 20 milliseconds.

In some embodiments, the location of the pixels in the micro-display tobe activated to form the outer image toward the periphery of the retinais referenced from the optical center of the eyeglass optics, since itis the point of regard at primary gaze. In some embodiments, thelocation of the point of regard is calculated by taking into account eyemovement relative to the position of the eye at primary gaze andcalculating the location of the pixels to be activated with reference tothe new point of regard. For example, FIG. 1A shows active pixels 94when a patient is looking level and straight ahead, so-called primarygaze, while FIG. 1B shows active pixels 94 when a patient is looking upand to the left. In such a case, the shape of the array of pixels may bethe same, but translated up and to the left, or the shape of the arraymay change. In some embodiments, the plurality of light sources, e.g.active pixels 74, are configured to change so as to maintain alignmentof the optical axis of the eye. This alignment can be provided withprocessor instructions configured to selectively activate pixels inaccordance with the eye movement and the optical axis of the eye.

In some embodiments a near eye display module is mounted on the outerside of a spectacle lens. Alternatively, the near eye display can bemounted on an inner side of a spectacle lens. In some embodiments, thedevice is binocular and comprises a micro-display and optics for eacheye of the wearer. The micro-display can be optically coupled with oneor more micro-optical components, designed to substantially collimatethe illumination generated by the pixels of the micro-display andrendered convergent, before entering the pupil.

In some embodiments, a display 72, e.g. a display module, is mounted onthe outer side of a spectacle lens and aligned with the spectacle lensoptic such that the near eye display can provide a field of view of+/−40 degrees or greater, so that the micro-display can continue toprovide peripheral retinal stimulus for the normal range of eyemovements, typically +/−15 degrees laterally, such as +/−5 degreeslaterally, and +10 to −20 degrees vertically, such as +/−7, or +/−20degrees vertically, including downgaze when reading or viewing nearobjects. In some embodiments, light from the micro-display istransmitted through the spectacle lens optic and provided with therefractive correction of the wearer.

In embodiments, the refractive correction comprises one or more of aspherical correction, or a correction for astigmatism. In someembodiments, the correction comprises a prismatic correction forcorrection of strabismus and correction for inadequate accommodationthat can vary across the spectacle lens optic, such as a progressiveaddition lens (“PAL”). In some embodiments, the micro-optic of the neareye display is configured to provide myopic defocus required to generatethe peripheral retinal stimulation for the prevention of myopiaprogression as described herein, for example with stimulation to outerregions of the retina with images formed anteriorly to the retina.

In some embodiments, the optical system is configured to form the imagesanterior to the retina and comprises one or more of a single micro-lens(lenslet), a plurality of micro-lenses (lenslet array), a compound lens,such as a Gabor lens, a micro-prism, or a micro-mirror, or a combinationthereof. In some embodiments, light baffles and micro-mirrors arearranged to ensure that the amount of light not captured by themicro-optic is substantially decreased, e.g. minimized, in order toreduce stray light and light escaping from the front side of thedisplay.

In some embodiments, a pixel fill factor less than 10% (0.1) issufficiently sparse to provide a clear view of the foveal and macularimage. In some embodiments, the fill factor is in the range of 0.01 to0.3 and can be within a range from 0.05 to 0.20. For example, an arrayof pixels of pixel size 5 microns and a pixel pitch of 20 microns leadsto a fill factor of 0.06. A low fill factor may also reduce thecomplexity of the manufacturing process and reduces the cost of suchmicro-optic displays.

In some embodiments, the micro-optic array is designed to be opticallyaligned with the display, so that light from a single or a plurality ofpixels 94 can be collected, collimated and focused to be directed to thepupil of the wearer at primary gaze. The density of these micro-opticalelements can control the overall visibility of the near eye display. Insome embodiments, the micro-optic has a low fill factor (preferablyequal to or less than 0.1) so that the overall light transmissionthrough the near eye display will be acceptable to wearers and allow thepatient to view objects.

In some embodiments the device comprises a switchable micro-optic arraythat can be switched between a plano (no optical power) state and anactivated state by electro-optical components, utilizing for example aliquid crystal or a LC based material that can be switched from onerefractive index to another, or one polarization to another, forexample. In some embodiments, the micro-optic array does not scatterlight or distort images of the real world when it is not activated.

In some embodiments, the location of the pixels in the micro-display tobe activated to form the outer image toward the periphery of the retinais referenced from the optical center of the eyeglass optics, since itis the point of regard at primary gaze. In some embodiments, thelocation of the point of regard is calculated by taking into account eyemovement relative to the position of the eye at primary gaze andcalculating the location of the pixels to be activated with reference tothe new point of regard.

In some embodiments, a plurality of pixels is activated to form thelight source that is imaged by the micro-optics. The optical design ofthe micro-optics and its separation from the micro-display can beconfigured to provide the focal length of the image delivery system, theimage magnification of the image projected on the retina and the blurcaused by diffraction, as measured as the Airy disc diameter of theoptical delivery system.

The technical specifications are given in Table 1, in accordance withsome embodiments.

TABLE 1 Optical specifications of the augmented reality near eye displayfor prevention of myopia progression. Optical Specification PreferredMagnitude Range Field of View +/−25 degrees (50 degrees 40-80 degreestotal) or +/−10 degrees (20 or 5-80 degrees degrees total) Eye Box 8 mm4-10 mm Eye relief 15-18 mm 15-25 mm Optical power Myopic defocus of3.5D 2.0D to 5.0D additional to or 2.0D to 7.0D refractive correctionDisplay color Green Polychromatic (RGB) or white Brightness 300-500cd/m2 100-10,000 cd/m2 or 100-1000 cd/m2 Resolution 2.5 min arc/pixel1-10 min arc/pixel or 1.0 min arc/pixel

Optical resolution or quality of the peripherally projected image can berelated to three factors: depth of focus, image magnification and Airydisk diameter. Depth of focus of near eye display depends on the focallength and the aperture of the near eye display as well as imagemagnification (Equation 1).

Depth of focus=2N*c*(1+m)  (Equation 1)

when N is the f number (f/D, where f is focal length and D is diameter),c is the minimum circle of confusion and m is image magnification.

In typical eyes, a myopic defocus of 1.0 D causes the image at bestfocus to move forward by 0.35 mm approximately.

The resolution of the retina decreases with eccentricity, so thatretinal resolution in the desired range of eccentricity drops to 20 linepairs/mm at eccentricities in the range of 20-40 degrees. It has beenfound that even at these eccentricities, the retina is capable ofdetecting the presence of a stimulus at a higher level of spatialfrequency. Accordingly, in some embodiments the micro-optic arraydesigned to form and project a peripheral image is corrected for opticalaberrations and is capable of forming an image for which the modulus ofOTF is equal to or better than 0.3 at a spatial frequency of 50 lp/mm orgreater.

Work in relation to the present disclosure suggests that the retinaperceives changes in image blur caused by higher order aberrationspresent in the defocused image (in addition to the spherical defocus),including longitudinal chromatic aberration (LCA), higher orderspherical aberration, astigmatism, etc. that are sensitive to the signof the defocus. Based on the teachings provided herein a person ofordinary skill in the art can conduct experiments to determine whetherthe retina can recognize a myopic blur from a hyperopic blur when thedepth of focus of the device is greater than or nearly equal to themagnitude of defocus. The device as described herein can beappropriately configured to provide appropriate amounts of defocus atappropriate locations, for example.

The device can be configured to provide appropriate image magnification,diffraction that limits the image resolution and depth of focus inrelation to the magnitude of myopic defocus being applied and the rateof change of image blur or image sharpness gradient as a function of themagnitude of defocus. The human eye may have a lower threshold of blurperception. Since the intensity of the growth signal to the retina andthe choroid depends on the magnitude of myopic defocus perceived interms of image defocus, the extent of defocus and blur perception can beconsidered in estimating the expected strength of growth signalgenerated by a particular optical configuration relative to themagnitude of myopic defocus applied to the retinal image by the near eyedisplay.

In some embodiments, the near eye display is configured to provide aclear, substantially undistorted field of view of the foveal and macularimage for comfortable vision. In some embodiments, the field of view ofthe central image is at least +/−12 degrees or at least +/−5 degrees andcan be more in order to account for differences in interpupillarydistance (IPD) of different wearers. Image quality and field of view ofthe real image can be provided with a substantially transparent near eyedisplay transparent, and by reducing the fill factor of light emittingpixels in the micro-display. In some embodiments, a fill factor lessthan 10% (0.1) is sufficiently sparse to provide a clear view of thefoveal and macular image. In some embodiments, the fill factor is in therange of 0.01 to 0.3 and can be within a range from 0.05 to 0.20. Forexample, an array of pixels of pixel size 5 microns and a pixel pitch of20 microns will lead to a fill factor of 0.06. A low fill factor mayalso reduce the complexity of the manufacturing process and reduces thecost of such micro-optic displays.

In some embodiments, the micro-optic array is designed to be opticallyaligned with the display, so that light from a single or a plurality ofpixels can be collected, collimated and focused to be directed to thepupil of the wearer at primary gaze. The population density of thesemicro-optical elements can control the overall visibility of the neareye display. In some embodiments, the micro-optic has a low fill factor(preferably equal to or less than 0.1) so that the overall lighttransmission through the near eye display will be acceptable to wearers.

In some embodiments the device comprises a switchable micro-optic arraythat can be switched between a plano (no optical power) state and anactivated state by electro-optical components, utilizing for example aliquid crystal or a LC based material that can be switched from onerefractive index to another, or one polarization to another, forexample. In some embodiments, the micro-optic array does not scatterlight or distort images of the real world when it is not activated.

Retinal Stimulation Light Sources and Circuitry

FIG. 2A shows OLED micro displays 12 mounted on the inner surface of alens such as a soft contact lens 10, optically coupled with micro lensarrays for projecting images with defocus on the periphery of the retinaof a wearer.

FIG. 2B shows a lens such as a soft contact lens 10 comprising aplurality of light sources and optics and associated circuitry, inaccordance with some embodiments.

Although FIGS. 2A and 2B refer to a contact lens, the lens may comprisea lens of one or more of a projector, an ophthalmic equipment, a TVscreen, a computer screen, a handheld device such as a smart phone, awearable device such as a spectacle lens, a near eye display, ahead-mounted display, a goggle, a contact lens, a corneal onlay, acorneal inlay, a corneal prosthesis, or an intraocular lens.

The contact lens 10 comprises a plurality of projection units 18. Eachof the plurality of projection units 18 comprises a light source and oneor more optics to focus light in front of the retina as describedherein. Each of the optics may comprise one or more of a mirror, aplurality of mirrors, a lens, a plurality of lenses, a diffractiveoptic, a Fresnel lens, a light pipe or a wave guide. The contact lens 10may comprise a battery 20 and a sensor 22. The contact lens 10 maycomprise a flex printed circuit board (PCB) 24, and a processor can bemounted on the PCB 24. The processor can be mounted on the PCB 24 andcoupled to the sensor 22 and the plurality of light sources 30. The softcontact lens 10 may also comprise wireless communication circuitry andan antenna for inductively charging the contact lens 10. Althoughreference is made to a battery 20, the contact lens 10 may comprise anysuitable energy storage device. The soft contact lens 10 may comprise alens body composed of any suitable material such as a hydrogel. Thehydrogel can encapsulate the components of the soft contact lens 10.

The processor can be configured with instructions to illuminate theretina with the plurality of light sources 30. The processor can beprogrammed in many ways, for example with instructions received with thewireless communication circuitry. The processor can receive instructionsfor a user mobile device.

The sensor 22 can be coupled to the processor to allow the user tocontrol the contact lens 10. For example, the sensor 22 can beconfigured to respond to pressure, such as pressure from an eyelid. Theprocessor can be coupled to the sensor 22 to detect user commands.

The electronic control system may comprise a processor such as an ASICor a microcontroller, a rechargeable Lithium ion solid state battery, avoltage ramping module e.g., a buck boost converter, a flash memory andan EEPROM, an RFID module to provide wireless recharging, or an antennapreferably disposed radially near an edge of the contact lens 10, andany combination thereof. The contact lens 10 may comprise abiocompatible material, such as a soft hydrogel or silicone hydrogelmaterial, and may comprise any material composition that has proven tobe compatible with sustained wear on the eye 11 as a contact lens 10.

FIG. 2C shows mechanical integration of the function of the componentsof the lens such as a contact lens 10 as in FIG. 2B. These componentscan be supported with the PCB 24. For example, the power source such asa battery 20 can be mounted on the PCB 24 and coupled to othercomponents to provide a power source function 21. The sensor 22 can beconfigured to provide an activation function 23. The sensor 22 can becoupled to a processor mounted on the PCB 24 to provide a controlfunction 25 of the contact lens 10. The control function 25 may comprisea light intensity setting 27 and a light switch 29. The processor can beconfigured to detect signal from the sensor 22 corresponding to anincrease in intensity, a decrease in intensity, or an on/off signal fromthe sensor 22, for example with a coded sequence of signals from thesensor 22. The processor is coupled to the light projection units 18which can comprise a light source 30 and optics 32 to provide theprojection function 31. For example, the processor can be coupled to theplurality of light sources 30 to control each of the light sources 30 inresponse to user input to the sensor 22.

Optical Configurations and Projection Optics

In some embodiments, the optic configuration 32 comprises a plurality ofmirrors configured to collect light emitted by the micro-displays 12,then direct the light beam to the pupil of the eye 11, in order to forman eccentric retinal image, as shown in FIGS. 3 and 4. The mirrors maycollimate the light beam, or direct the light beam toward the retina 33with a suitable vergence so as to focus the light beam onto the retina33.

Although the optic configurations shown in FIGS. 3 and 4 refer to alens, such as a contact lens, a similar optical configuration can beused with a lens of one or more of a projector, an ophthalmic equipment,a TV screen, a computer screen, a handheld device such as a smart phone,a wearable device such as a spectacle lens, a near eye display, ahead-mounted display, a goggle, a contact lens, a corneal onlay, acorneal inlay, a corneal prosthesis, or an intraocular lens. Also,although reference is made to a myopic defocus, the defocus may comprisea hyperopic defocus, or an image focused onto the retina, for example.

The specifications of an exemplary optical configuration are shown inTable 2.

TABLE 2 Basic optic parameters of the optic configuration shown in FIG.3. Value (Reflective Value (Single Characteristics Design) Lens Design)Size of the light source 10 microns 10 microns Diameter of the optic 1.1mm 0.292 mm Decentration of the light 1.75 mm 1.75 mm source from thecenter of the contact lens Wavelength 507 nm 507 nm Thickness of optic300 microns 250 microns Retinal image location 27 degrees eccentric 27degrees eccentric Size of the retinal image 200 microns 1100 microns

A comparison of the simulated image size for the optic configurationshown in FIG. 3 and the retinal resolution at 27 degrees eccentricityshows that the peripheral retina 33 at this eccentricity will be able toperceive this image.

In some embodiments, three performance attributes of the opticconfiguration include one or more of:

1. Image magnification, controlling image resolution;

2. Depth of focus, controlled by the optical path length of the opticconfiguration; and

3. Diffraction, as measured by the Airy Diameter.

The mirror assembly shown in FIG. 3 achieves a depth of focus that isless than 1 D, enabling the applied defocus of 2.0 to 4.0 D or 2.0 to7.0 D to be clearly perceived by the peripheral retina 33 at thespecified eccentricity (20 to 30 degrees or 10 to 40 degrees).

In some embodiments, the spots size of the image focused in front of theretina 33 comprises a resolution finer than the resolution of the retina33. Retinal resolution generally decreases as a function ofeccentricity. For example, at an angle of 0 degrees of eccentricity,retinal resolution is approximately 10 micrometers. At 5 degrees ofeccentricity, the retinal resolution is approximately 30 micrometers. At20 degrees of eccentricity, the resolution is approximately 100micrometers and at 30 degrees the retinal resolution is approximately150 micrometers.

FIGS. 5A and 5B show analysis of retinal image quality generated by theoptic configuration of FIG. 3. Images formed by three of the four lightsources 30 have been simulated. The temporal point has been omittedbecause it is symmetrical to the nasal point. The analysis shows thatthe image quality exceeds the resolving power of the retina 33 at 27degrees eccentricity. The modulation transfer function of the retinalimage created by the mirror assembly of FIG. 3 is diffraction limited,indicating that aberrations of the optical elements deployed are notcausing significant deterioration of image quality, in accordance withthis embodiment. Furthermore, the spatial resolution of the opticsexceeds the resolution of the retina 33 at the preferred image location.

FIG. 6 shows analysis of depth of focus of the optic configuration shownin FIG. 3. Each millimeter of distance from the retina 33 represents adefocus of 2.7 D. This analysis shows that the depth of focus issufficiently small that a defocus of 0.5 mm (1.35 D) is perceivable bythe retina 33 at the point of incidence of the image (27 degreeseccentricity). Depth of focus depends on effective path length of thestimulating beam.

FIG. 7 shows the plot of MTF values against defocus shows the depth offocus of image created by each of the light sources (object).

A second embodiment comprises optics 32 comprising a converging orcollimating lens in optical coupling with light source 30, as shown inFIGS. 8A and 8B. In this configuration a lens 34, which may comprise asingle lens, is used to collimate the light output from the stimulationsource and direct it to the cornea 37 through the lens such as contactlens 10. Although reference is made to a contact lens, the lens 10 maycomprise a lens of one or more of a projector, an ophthalmic equipment,a TV screen, a computer screen, a handheld device such as a smart phone,a wearable device such as a spectacle lens, a near eye display, ahead-mounted display, a goggle, a contact lens, a corneal onlay, acorneal inlay, a corneal prosthesis, or an intraocular lens.

The effectiveness of the collimating lens 34 depends on its refractiveindex and should be sufficiently high in order to create a substantialdifference in refractive indices between the lens material and thematerial of the contact lens 10 that functions as the substrate. In thisexample, the refractive index of the embedded lens 34 has been assumedto be 2.02 (e.g., refractive index of a lanthanum fluorosilicate glassLaSF₅), although other materials may be used.

Optical performance of the embodiment of FIGS. 8A and 8B is shown inFIGS. 9 and 10. Images formed by three of the four light sources 30 havebeen simulated. The temporal point has been omitted because it issymmetrical to the nasal point. Each millimeter of distance from theretina 33 represents a defocus of 2.7 D. This analysis shows that thedepth of focus is substantially higher than 1 D, so that image blurcaused by a defocus of 0.5 mm (1.35 D) may not be perceivable by theretina 33 at the point of incidence of the image (27 degreeseccentricity).

The analysis shows that the image quality exceeds the resolving power ofthe retina 33 at 27 degrees eccentricity. The optical path length of thesingle lens design is much shorter in this case, therefore, imagemagnification is substantially higher (110×, as opposed to 8× or 20× forthe reflective design.). The spatial frequency resolution at 50%contrast (Modulus of OTF) is lower, approximately 15 line pairs permillimeter (“lp/mm”), compared with 50 lp/mm for the reflective design.Depth of focus has been estimated for this embodiment, again using LiouBrennan eye model to simulate the ocular optics, including ocularaberrations, as shown in FIG. 10. The depth of focus is greater than 1.0D, indicating that changes in image resolution as a function of defocusmay not be easily perceivable by the peripheral retina 33, especiallysince the resolution capability of the retina 33 at that eccentricity(20 to 30 degrees or 10 to 30 degrees), derived mainly from rods isrelatively poor as described herein.

A third embodiment comprises a light-pipe 36 in order to increase theoptical path length, as shown in FIGS. 11A and 11B. The light-pipe 36can provide an increased optical path length to decrease imagemagnification and retinal image size. However, depth of focus isrelatively large, and the resolution is relatively coarse (15 lp/mm at50% MTF).

Although reference is made to a light pipe 36 on a cornea 37 as wouldoccur with a contact lens, the lens combined with the light pipe 36 maycomprise a lens of one or more of a projector, an ophthalmic equipment,a TV screen, a computer screen, a handheld device such as a smart phone,a wearable device such as a spectacle lens, a near eye display, ahead-mounted display, a goggle, a contact lens, a corneal onlay, acorneal inlay, a corneal prosthesis, or an intraocular lens.

Numerous other optical configurations may be used, including the use ofa micro-lens array with a point source, use of diffractive optics inorder to use a thinner lens, generation of multiple retinal images usinga single point source and an optical processing unit. In all case, thethree characteristics listed above may be used as metrics in order toevaluate the suitability of a particular design.

Each embodiment disclosed herein can be combined with any one or more ofthe other embodiments disclosed herein, and a person of ordinary skillin the art will recognize many such combinations as being within thescope of the present disclosure.

Exemplary Lens Embodiments

The presently disclosed methods and apparatus are well suited forcombination with many types of lenses, such as one or more of: smartcontact lenses, contact lenses with antennas and sensors, contact lenseswith integrated pulse oximeters, contact lenses with phase map displays,electro-optic contact lenses, contact lenses with flexible conductors,autonomous eye tracking contact lenses, electrochromic contact lenses,dynamic diffractive liquid crystal lenses, automatic accommodationlenses, image display lenses with programmable phase maps, lenses withtear activated micro batteries, tear film sensing contact lenses, lenseswith multi-colored LED arrays, contact lenses with capacitive sensing,lenses to detect overlap of an ophthalmic device by an eyelid, lenseswith active accommodation, lenses with electrochemical sensors, lenseswith enzymes and sensors, lenses including dynamic visual fieldmodulation, lenses for measuring pyruvate, lenses for measuring urea,lenses for measuring glucose, lenses with tear fluid conductivitysensors, lenses with near eye displays with phase maps, or lenses withelectrochemical sensor chips.

A lens such as a soft contact lens 10 is shown in FIG. 12. Althoughreference is made to a contact lens, the lens 10 may comprise a lens ofone or more of a projector, an ophthalmic equipment, a TV screen, acomputer screen, a handheld device such as a smart phone, a wearabledevice such as a spectacle lens, a near eye display, a head-mounteddisplay, a goggle, a contact lens, a corneal onlay, a corneal inlay, acorneal prosthesis, or an intraocular lens.

This contact lens 10 comprises a base or carrier contact lens comprisingembedded electronics and optics. The base soft contact lens 10 is madeof a biocompatible material such as a hydrogel or a silicone hydrogelpolymer designed to be comfortable for sustained wear. In someembodiments, the contact lens 10 has a central optical zone 14 ofdiameter within a range from 6 mm to 9 mm, for example within a rangefrom 7.0 mm to 8.0 mm. The central optical zone 14 is circumscribed byan outer annular zone, such as a peripheral zone 16 of width in a range2.5 mm to 3.0 mm. The outer annular zone is surrounded by an outermostedge zone 18 of width in the range from 0.5 mm to 1.0 mm. The opticalzone 14 is configured to provide refractive correction and can bespherical, toric or multifocal in design, for example. The outer annularzone peripheral to the optical zone 14 is configured to fit the cornealcurvature and may comprise rotational stabilization zones fortranslational and rotational stability, while allowing movement of thecontact lens 10 on the eye 11 following blinks. The edge zone 18 maycomprise a thickness within a range from 0.05 mm to 0.15 mm and may endin a wedge shape. The overall diameter of the soft contact lens 10 canbe within a range from 12.5 mm to 15.0 mm, for example within a rangefrom 13.5 mm to 14.8 mm.

The embedded light sources 30 and the electronics are preferably locatedin the outer annular zone of the contact lens 10, as shown in FIG. 12.The central optical zone 14 is preferably free from electronics andlight sources 30 in order to not compromise the quality of centralfoveal or macular vision, in accordance with some embodiments. In someembodiments, the edge zone 18 does not comprise circuitry in order tomaintain contact with the corneal surface and provide comfort.

The light sources can be arranged in many ways on the contact lens. Forexample, the light sources can be arranged in a substantially continuousring around the central optical zone. In some embodiments, the pluralityof light sources and the plurality of optics (e.g., lenses, mirrors orlight guides) are coupled together to form a continuous ring ofillumination.

The contact lens 10 of FIG. 12 comprises of a body composed of a softbiocompatible polymer with high oxygen permeability embedded with atransparent film populated with all the electronic and opticalcomponents. This transparent film may comprise a transparent printedcircuit board (“PCB”) substrate. The thickness of the PCB can be withina range from about 5 microns to 50 microns and may comprise a pluralityof layers of the film in order to utilize both surfaces of the PCBsubstrate for population of electronics. The PCB substrate can be curvedto conform to the geometry of the base contact lens 10, with a curvaturewithin a range about 7.5 mm to about 10.0 mm, for example within a rangefrom about 8.0 mm to about 9.5 mm, for example. The PCB substrate can beconfigured for suitable oxygen permeability. In some embodiments, thePCB is perforated to improve permeability of oxygen, tear fluid,nutrients and carbon dioxide through it. In some embodiments, the PCBhas a low tensile modulus, for example within a range from about 1 MPato about 50 MPa, although stiffer films may also be used for example. Insome embodiments, a preferred material for a transparent flexible PCBsubstrate comprises a polyimide that is cast from a liquid or asolution, and may be in the form of a polyamic acid when spin cast on aflat substrate, subsequently cured thermally to form a polyimide such asKapton™.

The contact lens 10 may comprise one or more components shown in FIG.12. The architecture of the electronic system, shown in FIG. 12comprises a plurality of light sources 30 mounted on a bus, amicrocontroller 38 that comprises a power and data management system, anonboard memory and an RFID module, a sensor that is designed to detect aphysical or physiological trigger and issue a signal that turns thelight sources 30 ON or OFF, an antenna 41 for wireless exchange of datathat also functions as a wireless receiver of power, operating on asingle or multiple frequency bands for transmission of data and powerand a rechargeable solid state Lithium ion battery 20. In someembodiments, the microcontroller 38 comprises an application specificintegrated circuitry (“ASIC”). The plurality of light sources 30 maycomprise microscopic light sources 30 as described herein.

The light sources 30 can be positioned along a circumference of diameterin the range 1.5 mm to 5.0 mm from the center.

FIG. 13 shows a ray tracing analysis of the image of a light source 30formed on an outer region of the retina 33 such as the peripheral retina33. In this simulation, the anterior chamber depth is assumed to be 4.1mm, typically between 2.9 mm and 5.0 mm for human subjects, the axiallength has been assumed to be 25.0 mm, and the contact lens 10 ispositioned on the cornea. The microscopic light source 30 is placed 1.9mm away from the center of the contact lens 10, leaving a centraloptical zone 14 of 3.8 mm in diameter that is clear.

Referring again to FIGS. 12 and 13, a combination of a light source 30and a lens such as a micro-lens can be used to direct light to an outerregion of the retina 33. The micro-lens can be configured to collectlight emitted by the light source 30. The collected light can be one ormore of collimated or focused and directed to the pupil of the eye 11.In some embodiments, a projection system comprises the combination ofthe microlight source 30 and the image forming optics 32.

The light source 30 may comprise one or more of an organic lightemitting diode (OLED), a quantum dot light emitting diode (QLED), atransparent light emitting diode (TOLED), an inorganic light emittingdiode (i-LED), a CRT display, or a Vertical Cavity Surface EmittingLaser (VCSEL). The light source 30 may comprise one or more pixels,populated on a transparent or opaque substrate. The light source 30 maycomprise one or more display components such as a passive matrix or anactive matrix, for example. In some embodiments, a size of individualpixels is within a range from 1 to 10 microns, for example within arange from 2 to 5 microns. The brightness of each of the plurality ofpixels when turned ON can be more than 500 nits (Cd/m²), more than 5000nits, or within a range from 10,000 to 25,000 nits.

The resolving power of the retina 33 is highest at the center, thefovea. Healthy young persons are capable of angular resolution of 0.6arc minute, equivalent to 20/12 in Snellen terminology. Resolutioncapability is typically reduced to 20/200 (10 arc minute) at 25 degreeseccentricity. There are few if any cones at this eccentricity, and thepopulation of rods is also much diminished.

In some embodiments, the image delivery system provides an imageresolution equal or exceeding the level of retinal image resolution. Insome embodiments, there is no additional benefit can be expected if theprojected image resolution exceeds the resolution capability of theretina 33 at the location of the image. In some embodiments, the spotsize of the image at the retinal periphery is therefore 150 microns orless.

The wavelengths of light emitted by the light source 30 can beconfigured in many ways. The wavelength of light emitted by the lightsource 30 can be determined by clinical studies in accordance with thepresent disclosure. In some embodiments, the wavelength of the lightsource 30 comprises light that corresponds to the peak sensitivity ofretinal photoreceptors at the desired eccentricity, e.g. substantiallymatches the peak sensitivity. In some embodiments light is projected atan eccentricity of 10 to 30 degrees, such as 20 to 30 degrees, whererods are predominant, and the light from the source compriseswavelengths within a range from about from about 410 nm to 600 nm, suchas 420 nm to 600 nm, for example from about 490 nm to 530 nm, forexample within a range from about 500 to 520 nm, for example from about502 to 512 nm. In some of the wavelength simulations disclosed herein507 nm light is used as the input wavelength parameter. The opticaldesigns disclosed herein are applicable to all wavelengths, even thoughthe precise results of optimized design parameters may change withwavelength, due to chromatic dispersion of the material comprising theprojection unit.

Work in relation to the present disclosure suggest that two designconstraints may influence the selection of design input parameters insome of the embodiments that follow. These are:

1. Dimensions of the projection unit 18, so that they can be embeddedinto the contact lens 10 without the lens thickness being too high. Insome embodiments, the maximum lens thickness in the outer annular zoneis 400 microns, which is consistent with current soft contact lenses forrefractive corrections.

2. Optical path length between the microscopic light source 30 and theimage forming system. This is related to control of image magnificationand magnitude of image blur caused by diffraction, which can bequantified as the Airy Disk diameter. Image magnification is given bythe ratio of the focal length of the image projection unit to the focallength of the eye 11, which is generally assumed to be 17 mm for firstorder estimates. In some embodiments, it is specific to the individualeye. In some embodiments, the Airy disk diameter, (2.44×λ(inmicrons)×f/≠) is no more than the retinal resolution limit at imagelocation. For example, the minimum spot size at eccentricity of 25degrees is 150 microns, so the Airy Disk diameter should not exceed 150microns and can be less than 150 microns. Since the focal length of theeye 11 is fixed, the aperture of the projection optic controls the AiryDisk diameter at any wavelength.

In some embodiments, size of the Airy Disk of the collection optics andlight sources 30 and associated image as described herein is related tothe retinal image resolution. For example, at 30 degrees, 25 degrees, 20degrees, 15 degrees and 10 degrees, the Airy Disk size may be no morethan about 150 micro-meters (“microns”, “um”) about 125 um, about 100um, about 75 um, and about 60 um, respectively.

The image forming system can be configured in many ways includingwithout limitation, diffractive optical elements, Fresnel lenses,refractive optics or reflective optics.

The following simulations provide optical results in accordance withsome embodiments disclosed herein.

TABLE 3 Input parameters of the second optical simulations. OpticalComponent or property Value Size of Light Source 10 microns MaxThickness of the light projection unit 300 microns Image location on theretinal periphery 27° eccentric to the fovea Diameter of the projectionunit 1.1 mm Optic design Aspheric 8^(th) order, 4^(th) order Zernikepolynomials Offset between the center of the contact 1.75 mm lens andthe light projection unit Wavelength of Light 507 nm

In some embodiments, the area covered by the overall image is preferablyan arcuate segment of 5-10 degrees by 30-45 degrees, or 150-450 degree²for every light source, or about 3.0-6.0 mm² in area. In someembodiments, four such light sources 30 at each quadrant of the contactlens 10 deliver four such peripheral images for optimum neurostimulationto the retina 33. An embodiment in accordance with the secondsimulations of the image delivery system is shown in FIG. 3. In thisembodiment, a system of convex 26 and concave 28 micro-mirrors is usedto increase optical path length and thereby image magnification of theperipheral retinal image. FIG. 4 shows the light path of the peripheralimage through the eye 11 for this embodiment. An exemplary light source30 can be defined, assuming that the diameter of the light source 30 is10 μm, and thickness is 100 μm. Four object points 40 can be specifiedto simulate the image quality, as shown in FIG. 14. With reference toFIG. 14, the simulated light source 30 is shown with the dashed circleof 10 μm and the simulated object points 40 includes the smaller circlesand the center points of each of the smaller circles. Table 3 shows theinput parameters of the simulation.

Output of the simulation are: Image magnification and size, Imagequality and Depth of focus. The same input and output parameters wereused to simulate all the preferred embodiments. Image size of the firstpreferred embodiment was found to be 200 microns, image magnificationbeing 20×. Results of simulation of image quality is shown in FIG. 15for this simulation. All MTF plots are virtually coincident. The MTFplots indicate that the resolution of the peripheral image issubstantially better than the limits of retinal resolution at thiseccentricity.

The depth of focus of the peripheral image was also simulated for thereflective optic in the second simulations and is shown in FIG. 16. Insome embodiments, the image is optimally formed at a distance of 2.0 mmin front of the retina 33, causing it to be myopically defocused on theretina 33. In some embodiments, the blur induced by this myopic defocusovercomes the effect of depth of focus, so that the retina 33 perceivesa blurred image for it to perceive a neurostimulation to move forward,reducing the axial length of the eye 11. In some embodiments, the neuralstimulation is sufficient to decrease axial growth of the eye 11.

FIG. 17 shows the effect of image blur caused by myopic defocus in theform of loss of contrast or the modulus of simulated MTF plots shown fora particular spatial frequency (20/200 or 10 arc minutes) for the secondsimulations. The increase in spot size shown in FIG. 16 is reflected inand consistent with the loss of the magnitude of the MTF plots as afunction of the magnitude of myopic defocus. The second simulationsindicate that the focal length of the projection unit is 0.85 mm with animage size 200 microns and an image magnification is 20×. The Airy diskdiameter is computed to be 8.9 microns, while the Raleigh criterion is10.9 microns.

Referring again FIGS. 8A and 8B which show a lens to collect light fromthe light source 30 and direct light toward the retina 33, and the pathof light along the eye 11, respectively. In some embodiments, the lightsource 30 faces a refractive lens that approximately collimates thelight which is finally projected in front of the peripheral retina 33,creating a myopic defocus of the peripheral image. Although reference ismade to a refractive lens, other lenses can be used such as diffractiveoptics and gradient index (GRIN) lenses. Table 4 shows the designparameters of the refractive lens used for the third simulations of theperipheral image.

TABLE 4 Design input parameters of the third simulations. LensParameters Value Diameter of the light source 10 microns Wavelength usedfor simulation 507 nm Diameter of the optic 292 microns Thickness of theoptic 250 microns Refractive index of the micro-lens 2.2 Image locationon the retina 27 degrees eccentric Thickness of the projection optic 350microns Distance of light source from center of contact lens 1.75 mmCollimating lens design 14^(th) order aspheric

The results of these simulations show that the image size is 1100microns with an image magnification of 110. The MTF plots are shown inFIG. 18 for the four object points 40 shown in FIG. 14. The magnitude ofMTF plots at high spatial frequencies are substantially lower than thosefor the reflective optic. The MTF plots show that image resolution isadequate for image of eccentricity 27 degrees. The optical design of thesecond preferred embodiment leads to a much greater depth of focus, asshown in FIG. 19. This means that in some embodiments the effectiveimage blur is much less for a myopic defocus in the range of 2D to 5 D,relative to the reflective optic, in accordance with the first andsecond simulations. The increased depth of focus is reflected in the MTFplots shown in FIG. 20, which may have a lesser dependence on themagnitude of myopic defocus relative to the reflective opticconfiguration, shown in FIGS. 3 and 4.

The third optical simulations show that the refractive optic maysuccessfully project a peripheral retinal image with an acceptable imagesize and image magnification and depth of focus. Although the imagesize, magnification and depth of focus may be somewhat larger than forthe reflective configuration of the second simulations.

Although MTF values at high spatial frequencies (50 lp/mm and above) arelower for this refractive optic design than the reflective design, imagequality at high spatial frequencies can be somewhat is less relevant atthe peripheral locations of the retinal image due to decreased visualacuity. The third simulations show that the focal length of theprojection unit is 0.15 mm with an image size of 1100 microns and animage magnification is 110×. The Airy disk diameter is computed to be36.7 microns, while the Raleigh criterion is 44.8 microns.

Referring again to FIGS. 11A and 11B, which shows a light guide, fourthsimulations were conducted for this configuration comprising a lightguide, a mirror and a lens. In the simulated embodiments, the focusinglens is located at the end (exit aperture) of the light pipe. In someembodiments, the light pipe comprises a curved lens surface on the endto focus light. In this lightguide embodiment, the projection opticcomprises a light guide comprising a mirror and a lens.

In some embodiments, the light source 30 is placed in an outer portionof the contact lens 10, e.g. near the periphery, and light from thesource is guided to a mirror that collects the light and deflects thelight towards the eye 11 to generate an image in front of the peripheralretina 33 with a myopic defocus as described herein. In someembodiments, the function of the light guide is to increase the lengthof the light path, so as to reduce image magnification and increaseresolution of the image formed anterior to the retina 33.

TABLE 5 Lens parameters used as inputs to the fourth simulations. OpticsProperty or Parameter Value Diameter of source 10 microns Wavelength ofsimulation 510 nm Length of Light Guide 2.7 mm Refractive index ofmaterial of projection 2.2 optics Diameter of mirror 400 micronsDecenter of optic relative to center of 1.75 mm contact lens Thicknessof optic 290 microns Image location 25 degrees eccentric to foveaOptical design and Image simulation Aspheric 6^(th) order, Zernike3^(rd) order

Table 5 gives the properties of the projection system used in the fourthsimulations of peripheral retinal image quality formed by light guideembodiments. Image magnification was 14 with an image size of 140microns. These simulations reveal that the image magnification isacceptable, the depth of focus is not as large as the refractive optic,but larger than the reflective optic. The fourth simulations indicatethat the focal length of the projection unit is 1.21 mm with an imagesize of 140 microns and a magnification of 14X. The Airy disk diameteris computed to be 34.8 microns, while the Raleigh criterion is 42.6microns.

The three results of the second, third and fourth simulations for thethree corresponding configurations were compared with one another interms of their size, the depth of focus produced by each defining asharpness gradient of the defocused image as a function of magnitude ofmyopic defocus, and the beam diameter. The results show that the secondsimulations comprising the reflective optic has the best sharpnessgradient, while the embodiment comprising the refractive optic has thesmallest sharpness gradient, with the lightguide based projection unitproviding a limited sharpness gradient, as shown in FIG. 24. Each ofthese approaches can be configured to decrease axial length growth inaccordance with the teachings disclosed herein.

The three embodiments also differ considerably in terms of the diameterof the optic, as shown in Table 6.

TABLE 6 Optic diameters used in the three simulations. ConfigurationOptic Diameter Reflective optic 1.1 mm Refractive optic 0.3 mmLightguide optic 0.4 mm

The reflective optic and light source 30 can be configured in many ways,and additional simulations can be conducted to determine appropriateconfigurations in accordance with the teachings disclosed herein. Forexample, clarity at the central object point shown in FIG. 14 can bedisregarded because its contribution to the neurostimulation is likelyto be limited. Such simulations and optimizations can allow a reductionof the diameter of the projection unit and its thickness, which can behelpful when the system is embedded into a contact lens 10 that providesa high level of comfort to wearers as described herein. The design inputparameters for a fifth simulation are shown in Table 7.

TABLE 7 Input parameters for the fifth simulation. Lens parameter ValueDiameter of light source 10 microns Wavelength 507 nm Diameter ofreflective lens optic 900 microns Decenter of the light source from the1.85 mm center of the contact lens Optic thickness 200 microns Thicknessof projection unit, including 200 microns light source Location ofperipheral retinal image 27 degrees eccentric to fovea Optic designAspheric 10^(th) order, Zernike polynomials, 4^(th) order

The results show that the image magnification can be increased to 25,providing an image size of 250 microns for a 10 micron source, which isacceptable for a peripheral image anterior to the retina 33 inaccordance with the embodiments disclosed herein. The output of thesefourth image simulations is shown in FIGS. 25 and 26. The sharpnessgradient, that is the variation of image spot size or MTF at a singlespatial frequency as a function of magnitude of myopic defocus are stillquite acceptable while providing a decreased size of the projectionsystem.

As detailed herein, the computing devices and systems described and/orillustrated herein broadly represent any type or form of computingdevice or system capable of executing computer-readable instructions,such as those contained within the modules described herein. In theirmost basic configuration, these computing device(s) may each comprise atleast one memory device and at least one physical processor.

The term “memory” or “memory device,” as used herein, generallyrepresents any type or form of volatile or non-volatile storage deviceor medium capable of storing data and/or computer-readable instructions.In one example, a memory device may store, load, and/or maintain one ormore of the modules described herein. Examples of memory devicescomprise, without limitation, Random Access Memory (RAM), Read OnlyMemory (ROM), flash memory, Hard Disk Drives (HDDs), Solid-State Drives(SSDs), optical disk drives, caches, variations or combinations of oneor more of the same, or any other suitable storage memory.

In addition, the term “processor” or “physical processor,” as usedherein, generally refers to any type or form of hardware-implementedprocessing unit capable of interpreting and/or executingcomputer-readable instructions. In one example, a physical processor mayaccess and/or modify one or more modules stored in the above-describedmemory device. Examples of physical processors comprise, withoutlimitation, microprocessors, microcontrollers, Central Processing Units(CPUs), Field-Programmable Gate Arrays (FPGAs) that implement softcoreprocessors, Application-Specific Integrated Circuits (ASICs), portionsof one or more of the same, variations or combinations of one or more ofthe same, or any other suitable physical processor.

Although illustrated as separate elements, the method steps describedand/or illustrated herein may represent portions of a singleapplication. In addition, in some embodiments one or more of these stepsmay represent or correspond to one or more software applications orprograms that, when executed by a computing device, may cause thecomputing device to perform one or more tasks, such as the method step.

In addition, one or more of the devices described herein may transformdata, physical devices, and/or representations of physical devices fromone form to another. For example, one or more of the devices recitedherein may receive image data of a sample to be transformed, transformthe image data, output a result of the transformation to determine a 3Dprocess, use the result of the transformation to perform the 3D process,and store the result of the transformation to produce an output image ofthe sample. Additionally or alternatively, one or more of the modulesrecited herein may transform a processor, volatile memory, non-volatilememory, and/or any other portion of a physical computing device from oneform of computing device to another form of computing device byexecuting on the computing device, storing data on the computing device,and/or otherwise interacting with the computing device.

The term “computer-readable medium,” as used herein, generally refers toany form of device, carrier, or medium capable of storing or carryingcomputer-readable instructions. Examples of computer-readable mediacomprise, without limitation, transmission-type media, such as carrierwaves, and non-transitory-type media, such as magnetic-storage media(e.g., hard disk drives, tape drives, and floppy disks), optical storagemedia (e.g., Compact Disks (CDs), Digital Video Disks (DVDs), andBLU-RAY disks), electronic-storage media (e.g., solid-state drives andflash media), and other distribution systems.

A person of ordinary skill in the art will recognize that any process ormethod disclosed herein can be modified in many ways. The processparameters and sequence of the steps described and/or illustrated hereinare given by way of example only and can be varied as desired. Forexample, while the steps illustrated and/or described herein may beshown or discussed in a particular order, these steps do not necessarilyneed to be performed in the order illustrated or discussed.

The various exemplary methods described and/or illustrated herein mayalso omit one or more of the steps described or illustrated herein orcomprise additional steps in addition to those disclosed. Further, astep of any method as disclosed herein can be combined with any one ormore steps of any other method as disclosed herein.

Unless otherwise noted, the terms “connected to” and “coupled to” (andtheir derivatives), as used in the specification and claims, are to beconstrued as permitting both direct and indirect (i.e., via otherelements or components) connection. In addition, the terms “a” or “an,”as used in the specification and claims, are to be construed as meaning“at least one of.” Finally, for ease of use, the terms “including” and“having” (and their derivatives), as used in the specification andclaims, are interchangeable with and shall have the same meaning as theword “comprising.

The processor as disclosed herein can be configured with instructions toperform any one or more steps of any method as disclosed herein.

It will be understood that although the terms “first,” “second,”“third”, etc. may be used herein to describe various layers, elements,components, regions or sections without referring to any particularorder or sequence of events. These terms are merely used to distinguishone layer, element, component, region or section from another layer,element, component, region or section. A first layer, element,component, region or section as described herein could be referred to asa second layer, element, component, region or section without departingfrom the teachings of the present disclosure.

As used herein, the term “or” is used inclusively to refer items in thealternative and in combination.

Each embodiment disclosed herein can be combined with any one or more ofthe other embodiments disclosed herein, and a person of ordinary skillin the art will recognize many such combinations as being within thescope of the present disclosure.

The present disclosure includes the following clauses.

Clause 1. A device to provide stimulation to a retina of an eye,comprising: one or more optics to project one or more images on theretina outside a fovea in order to promote one or more of a change in anaxial length or a choroidal thickness of the eye.

Clause 2. The device of clause 1 wherein said one or more imagescomprises one or more of a still image or a dynamic image.

Clause 3. The device of clause 2, wherein the image comprises thedynamic image with a refresh rate within a range from 1 Hz to 200 Hz.

Clause 4. The device of clause 1, wherein the one or more imagescomprises one or more of monochromatic light or polychromatic lightcomprising a wavelength within a range from 400 nm to 800 nm.

Clause 5. The device of clause 1, wherein said image has information orcontent in the spatial frequency range of 1 cycle per degree to 60cycles per degree and optionally from 1 cycle per degree to 10 cyclesper degree,

Clause 6. The device of clause 1, wherein said image comprises acontrast within a range from 99.9% to 2.5%.

Clause 7. The device of clause 1, wherein said image comprises aneccentricity with respect to a fovea within a range from 5, degrees to40 degrees.

Clause 8. The device of clause 7, wherein said image illuminates theretina within the range with a pattern extending substantiallycontinuously for 360 degrees around the fovea.

Clause 9. The device of clause 7, wherein said image illuminates aportion of the retina within the range.

Clause 10. The device of clause 1, further comprising circuitry tostimulate the retina with the one or more images with temporalillumination comprising one or more of continuous illumination,discontinuous illumination, periodic illumination or aperiodicillumination.

Clause 11. The device of clause 10, wherein the temporal illuminationcomprises the periodic illumination for a duration within a range from 1second to 24 hours.

Clause 12. The device of clause 10, wherein the temporal illuminationcomprises the discontinuous illumination for a duration within a rangefrom 1 second to 24 hours.

Clause 13. The device of clause 10, wherein said circuitry is configuredto illuminate the retina when the subject is one or more of awake,asleep, or asleep or awake.

Clause 14. The device of clause 1, further comprising circuitry tostimulate the retina with the one or more images with a spatialillumination pattern comprising one or more of a continuous spatialillumination pattern, a discontinuous spatial illumination pattern, aperiodic illumination pattern or an aperiodic spatial illuminationpattern.

Clause 15. The device of clause 1, wherein said one or more imagescomprises a brightness within a range 1 to 1000 Trolands.

Clause 16. The device of clause 1, wherein said one or more optics isconfigured to project said one or more images with a luminance with in arange from 100 to 50,000 nits or within a range from 1 to 10,000 nits.

Clause 17. The device of clause 1, wherein said one or more images iscorrected for a refractive error of the eye.

Clause 18. The device of clause 1, wherein said one or more images isdefocused with respect to one or more locations of the retina where theone or more images illuminates the retina.

Clause 19. The device of clause 18 wherein said one or more images ismyopically defocused within a range from 2.0 D to 7.0 D and optionallyfrom 2.0 D to 5.0 D.

Clause 20. The device of clause 18, wherein said one or more images ishyperopically defocused by an amount within a range from 2.0 D to 7.0 Dand optionally from 2.0 D to 5.0 D.

Clause 21. The device of clause 1, wherein said one or more opticscomprises a component of a light projection system.

Clause 22. The device of clause 21, wherein the light projection systemcomprises a component of one or more of a projector, an ophthalmicdevice, a TV screen, a computer screen, a handheld, a mobile computingdevice, a tablet computing device, a smart phone, a wearable device, aspectacle lens, a near eye display, a head-mounted display, a goggle, acontact lens, an implantable device, a corneal onlay, a corneal inlay, acorneal prosthesis, or an intraocular lens.

Clause 23. The device of clause 21, further comprising a support coupledto the projection system, the support comprising one or more of anophthalmic device, a TV screen, a computer screen, a handheld, a mobilecomputing device, a tablet computing device, a smart phone, a wearabledevice, a spectacle lens frame, a spectacle lens, a near eye display, ahead-mounted display, a goggle, a contact lens, an implantable device, acorneal onlay, a corneal inlay, a corneal prosthesis, or an intraocularlens.

Clause 24. The device of clause 1, comprising: a plurality of lightsources; wherein the one or more optics comprises a plurality ofprojection optics coupled to the plurality of light sources to project aplurality of images anterior to the retina.

Clause 25. The device of clause 24, wherein said plurality of projectionoptics is arranged to project the plurality of images of the pluralityof light sources at a plurality of outer regions of the retina of theeye with an eccentricity within a range from 5 degrees to 30 degreeswith respect to a fovea of the eye and optionally within a range from 15degrees to 30 degrees.

Clause 26. The device of clause 24, wherein each of said plurality ofprojection optics is arranged to project an image myopically defocusedwith respect to a retinal surface, wherein an amount of said defocus iswithin a range from 2.0 D to 7.0 D and optionally within a range from2.0 D to 5.0 D.

Clause 27. The device of clause 24, wherein each of said plurality ofprojection optics is located 1.5 mm to 5.0 mm from a center of a contactlens and optionally wherein the plurality of projection optics islocated along the circumference of a circle.

Clause 28. The device of clause 24, wherein said plurality of projectionoptics comprises a plurality of image forming optics optically coupledto said plurality of light sources to project the plurality of imagesanterior to the surface of the retina.

Clause 29. The device of clause 28, wherein each of said plurality oflight sources has a maximum distance across not exceeding 26 microns andoptionally no more than 10 microns and optionally wherein said maximumdistance across comprises a diameter.

Clause 30. The device of clause 28, wherein each of the plurality ofprojection optics comprises one or more of a mirror, a lens, or alightguide.

Clause 31. The device of clause 30, wherein each of the plurality ofimage forming optics comprising one or more of a diffractive element, aFresnel lens, or a compound Gabor lens.

Clause 32. The device of clause 30, wherein each of the plurality ofimage forming optics has a maximum distance across within a range from200 microns to 1.5 mm and optionally wherein said maximum distanceacross comprises a diameter.

Clause 33. The device of clause 30, wherein each of the plurality ofimage forming optics is aspheric and corrected for image aberrations.

Clause 34. The device of clause 30, wherein each of the plurality ofimage forming optics comprises a combination of convex and concavemirrors.

Clause 35. The device of clause 33, wherein said each of the pluralityof image forming optic forms an image anterior to an outer portion ofthe retina at an eccentricity within a range from 1 degree to 30 degreesfrom a fovea, optionally within a range from 10 degrees to 30 degreesfrom the fovea, optionally from 15 degrees to 30 degrees and furtheroptionally from 25 degrees to 30 degrees.

Clause 36. The device of clause 33, wherein said each of the pluralityof image forming optics creates an image anterior to the retina with animage of magnification within a range from 5 to 20 or within a rangefrom 25 to 100.

Clause 37. The device of clause 24, wherein the image anterior to theouter portion of the retina comprises a magnitude of modulation transferfunction of no less than 0.75 at a spatial frequency of 10 lp/mm, and noless than 0.40 at a spatial frequency of 30 lp/mm and optionally amagnitude of modulation transfer function of no less than 0.75 at aspatial frequency of 10 lp/mm, and no less than 0.40 at a spatialfrequency of 50 lp/mm.

Clause 38. The device of clause 30, wherein each of the plurality ofprojection optics comprises an image forming optic comprising acollimating optic configured to form the image anterior to the retina.

Clause 39. The device of clause 30, wherein said projection opticcomprises a single lens to function both as a collimating optic and animage forming optic.

Clause 40. The device of clause 30, wherein said projection opticcomprises an image forming optic to create an image anterior to an outerportion of the retina with eccentricity no more than 30 degrees and adepth of focus of no more than 1.0 D.

Clause 41. The device of clause 39, wherein said optic creates the imageanterior to an outer portion of the retain with an eccentricity no morethan 30 degrees, wherein a modulation transfer function of said imagedecreases by a minimum of 0.1 units for a defocus of 1.0 D andoptionally wherein the defocus of 1.0 D comprises an incrementaldefocus.

Clause 42. The device of clause 24, wherein the plurality of lightsources comprises a plurality of micro-displays.

Clause 43. The device of clause 24, wherein the plurality of lightsources comprises a plurality of light emitting diodes (LEDs).

Clause 44. The device of clause 24, wherein each of said plurality ofoptical elements comprises a mirror assembly that collimates lightemitted by a corresponding micro-display and directs a resulting lightbeam into the pupil of the eye, wherein said light beam is focused toform the peripheral image in front of the retina.

Clause 45. The device of clause 24, wherein each of said plurality ofoptical elements comprise a lens that receives light emitted by acorresponding micro-display and directs a resulting light beam into thepupil of the eye, wherein said light beam is focused to form an image infront of the retina.

Clause 46. The device of clause 24, wherein the plurality of lightsources generates a polychromatic illumination and optionally whereinthe plurality of light sources comprises a plurality of micro-displaysgenerating polychromatic illumination.

Clause 47. The device of clause 24, wherein said image is about 0.5 mmto 2.0 mm in front of the retina.

Clause 48. The device of clause 24, wherein said image has a resolutionof at least 10 lp/mm and optionally at least 30 lp/mm.

Clause 49. The device of clause 24, wherein said image has amagnification of no more than 200× and optionally no more than 100×.

Clause 50. The device of clause 24, wherein said image has a depth offocus no more than 2.5 diopters and optionally wherein said depth offocus is no more than about 0.9 mm.

Clause 51. The device of clause 24, wherein said image is projected atan eccentricity in the within a range from about 7.5 degrees to about 45degrees and optionally within a range from about 15 degrees to about 45degrees.

Clause 52. The device of clause 51, wherein said range is from about 15degrees to about 30 degrees.

Clause 53. The device of clause 24, wherein said micro-displayilluminates the pupil with an illuminance within a range from about 100cd/m2 to 50,000 cd/m2. Or within a range from about 0.1 cd/m2 to 10cd/m2

Clause 54. The device of clause 24, wherein the image is focused at adistance in front of the peripheral retina at a location and the imagecomprises a depth of focus and a spatial resolution, the depth of focusless than the distance, the spatial resolution greater than a spatialresolution of the peripheral retina at the location.

Clause 55. The device of clause 24, further comprising a sensor toreceive input from the wearer when the contact lens has been placed onan eye of the wearer.

Clause 56. A spectacle lens comprising a display wherein said displayprojects images at the periphery of the retina in order to decreaseprogression of myopia.

Clause 57. The spectacle lens of clause 56, wherein said displaycomprises a micro-display.

Clause 58. The spectacle lens of clause 56, wherein said displaycomprises a pico-projector coupled to an eyeglass frame at a locationcorresponding to a temple of a wearer.

Clause 59. The spectacle lens of clause 56, wherein said displaycomprises a near eye display.

Clause 60. The spectacle lens of clause 56, wherein said display isconfigured to stimulate inwards growth of the retina.

Clause 61. The spectacle lens of clause 56, wherein said displaycomprises a micro-display and a micro-optic array.

Clause 62. The spectacle lens of clause 56, wherein said display enablesclear viewing of the real world over a field of view in the range +/−2.0degrees to +/−15 degrees and optionally within a range from about +/−2.0degrees to +/−12.5 degrees.

Clause 63. The spectacle lens of clause 61, wherein said displayprojects images of light sources of said micro-display that aremyopically defocused by an amount within a range from 2.0 D to 7.0 D andoptionally within a range from 2.0 D to 5.0 D.

Clause 64. The spectacle lens of clause 56, wherein said displayprojects images at an outer region of the retina at an eccentricity tothe foveola within a range from 15 degrees to 40 degrees, and optionallywithin a range from 20 degrees to 30 degrees.

Clause 65. The spectacle lens of clause 56, wherein said lens comprisesa plurality of near eye displays in order to enable binocularstimulation of the outer retina.

Clause 66. The spectacle lens of clause 56, wherein said displaytransmits over 80% of light incident on it over a field of view not lessthan +/−5 degrees laterally and +/−7 degrees vertically and optionallynot less than +/−12 degrees laterally and +/−20 degrees vertically.

Clause 67. The spectacle lens or device of any one of the precedingclauses, wherein the projected images move to compensate for eyemovement and optionally wherein the projected images move to providestimulation to overlapping regions of the periphery of the retina inresponse to eye movement.

Clause 68. The spectacle lens or device of any one of the precedingclauses, wherein the periphery of the retina comprises an outer locationof the retina located away from the macula.

Clause 69. The device of any one of the preceding clauses, furthercomprising a processor coupled to the plurality of light sources tocontrol illumination of the plurality of light sources.

Clause 70. The device of any one of the preceding clauses, furthercomprising wireless communication circuitry operatively coupled to theplurality of light sources to control illumination of the plurality oflight sources.

Clause 71. The device of any one of the preceding clauses, furthercomprising wireless communication circuitry operatively coupled to amobile device for the wearer to control illumination of the plurality oflight sources.

Clause 72. The device of any one of the preceding clauses, furthercomprising wireless communication circuitry operatively coupled to aprocessor for a health care provider to program illumination cycles andintensities of the plurality of light sources.

Clause 73. The device of any one of the preceding clauses, wherein thedevice does not comprise a contact lens.

While preferred embodiments of the present invention have been shown anddescribed herein, it will be obvious to those skilled in the art thatsuch embodiments are provided by way of example only. It is not intendedthat the invention be limited by the specific examples provided withinthe specification. While the invention has been described with referenceto the aforementioned specification, the descriptions and illustrationsof the embodiments herein are not meant to be construed in a limitingsense. Numerous variations, changes, and substitutions will now occur tothose skilled in the art without departing from the invention.Furthermore, it shall be understood that all aspects of the inventionare not limited to the specific depictions, configurations or relativeproportions set forth herein which depend upon a variety of conditionsand variables. It should be understood that various alternatives to theembodiments of the invention described herein may be employed inpracticing the invention. It is therefore contemplated that theinvention shall also cover any such alternatives, modifications,variations or equivalents. It is intended that the following claimsdefine the scope of the invention and that methods and structures withinthe scope of these claims and their equivalents be covered thereby.

We claim as follows:
 1. A device to provide stimulation to a retina ofan eye, comprising: one or more optics to project one or more images onthe retina outside a fovea in order to promote one or more of a changein an axial length or a choroidal thickness of the eye.
 2. The device ofclaim 1, wherein the one or more images comprises one or more ofmonochromatic light or polychromatic light comprising a wavelengthwithin a range from 400 nm to 800 nm.
 3. The device of claim 1, whereinsaid image has information or content in the spatial frequency range of1 cycle per degree to 60 cycles per degree and optionally from 1 cycleper degree to 10 cycles per degree.
 4. The device of claim 1, whereinsaid image comprises a contrast within a range from 99.9% to 2.5%. 5.The device of claim 1, wherein said image comprises an eccentricity withrespect to a fovea within a range from 5, degrees to 40 degrees.
 6. Thedevice of claim 1, wherein said one or more images comprises abrightness within a range 1 to 1000 Trolands.
 7. The device of claim 1,wherein said one or more optics is configured to project said one ormore images with a luminance with in a range from 100 to 50,000 nits orwithin a range from 100 to 10,000 nits.
 8. The device of claim 1,wherein said one or more images is corrected for a refractive error ofthe eye.
 9. The device of claim 1, wherein said one or more images ismyopically defocused within a range from 2.0 D to 7.0 D and optionallyfrom 2.0 D to 5.0 D.
 10. The device of claim 1, wherein said one or moreoptics comprises a component of a light projection system.
 11. Thedevice of claim 10, wherein the light projection system comprises acomponent of one or more of a projector, an ophthalmic device, a TVscreen, a computer screen, a handheld, a mobile computing device, atablet computing device, a smart phone, a wearable device, a spectaclelens, a near eye display, a head-mounted display, a goggle, a contactlens, an implantable device, a corneal onlay, a corneal inlay, a cornealprosthesis, or an intraocular lens.
 12. The device of claim 1, whereinthe one or more optics comprises a plurality of projection opticscoupled to a plurality of light sources to project a plurality of imagesanterior to the retina, each of said plurality of projection optics isarranged to project an image myopically defocused with respect to aretinal surface, wherein an amount of said defocus is within a rangefrom 2.0 D to 7.0 D and optionally within a range from 2.0 D to 5.0 D.13. The device of claim 1, wherein the one or more optics comprises aplurality of projection optics coupled to a plurality of light sourcesto project a plurality of images anterior to the retina and each of theplurality of projection optics comprises one or more of a mirror, alens, or a lightguide.
 14. The device of claim 1, wherein the one ormore optics comprises a plurality of projection optics coupled to aplurality of light sources to project a plurality of images anterior tothe retina, the image anterior to the portion of the retina comprises amagnitude of modulation transfer function of no less than 0.75 at aspatial frequency of 10 lp/mm, and no less than 0.40 at a spatialfrequency of 30 lp/mm and optionally a magnitude of modulation transferfunction of no less than 0.75 at a spatial frequency of 10 lp/mm, and noless than 0.40 at a spatial frequency of 50 lp/mm.
 15. The device ofclaim 1, wherein the one or more optics comprises a plurality ofprojection optics coupled to a plurality of light sources to project aplurality of images anterior to the retina, said plurality of projectionoptics comprises a plurality of image forming optics optically coupledto said plurality of light sources to project the plurality of imagesanterior to the surface of the retina, and said projection opticcomprises an image forming optic to create an image anterior to an outerportion of the retina with eccentricity no more than 30 degrees and adepth of focus of no more than 1.0 D.
 16. The device of claim 15,wherein the one or more optics comprises a plurality of projectionoptics coupled to a plurality of light sources to project a plurality ofimages anterior to the retina, said plurality of projection opticscomprises a plurality of image forming optics optically coupled to saidplurality of light sources to project the plurality of images anteriorto the surface of the retina, each of the plurality of projection opticscomprises an image forming optic comprising a collimating opticconfigured to form the image anterior to the retina, and said opticcreates the image anterior to an outer portion of the retain with aneccentricity no more than 30 degrees, wherein a modulation transferfunction of said image decreases by a minimum of 0.1 units for a defocusof 1.0 D and optionally wherein the defocus of 1.0 D comprises anincremental defocus.
 17. The device of claim 1, comprising: a pluralityof light sources, wherein the plurality of light sources comprises aplurality of light emitting diodes (LEDs).
 18. The device of claim 13,wherein the one or more optics comprises a plurality of projectionoptics coupled to a plurality of light sources to project a plurality ofimages anterior to the retina and each of said plurality of projectionoptics comprises a mirror assembly that collimates light emitted by acorresponding micro-display and directs a resulting light beam into thepupil of the eye, wherein said light beam is focused to form theperipheral image in front of the retina.
 19. The device of claim 13,wherein the one or more optics comprises a plurality of projectionoptics coupled to a plurality of light sources to project a plurality ofimages anterior to the retina and the plurality of light sourcesgenerates a polychromatic illumination and optionally wherein theplurality of light sources comprises a plurality of micro-displaysgenerating polychromatic illumination.
 20. The device of claim 13,wherein the one or more optics comprises a plurality of projectionoptics coupled to a plurality of light sources to project a plurality ofimages anterior to the retina and said image has a depth of focus nomore than 2.5 diopters and optionally wherein said depth of focus is nomore than about 0.9 mm.
 21. The device of claim 13, wherein the one ormore optics comprises a plurality of projection optics coupled to aplurality of light sources to project a plurality of images anterior tothe retina and said plurality of light sources illuminates the pupilwith an illuminance within a range from about 100 cd/m² to 50,000 cd/m².22. The device of claim 1, wherein said device comprises one or moresensors, the sensors including of a global positioning system sensor anda pulse oximeter.
 23. The device of claim 22, wherein said device isoperably controlled based on readings from the one or more sensors. 24.The device of claim 1, wherein said one or more optics is configured toproject said one or more images with a luminance greater than 500 nits.